|
|
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| Cardinal Health Leader Blood Glucose Monitoring System |
| K073573 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
11/13/2009 |
| CLIAwaived, Inc. Rapid Fecal Occult Blood Test |
| K061065 |
Fecal Occult Blood |
General Chemistry |
11/09/2009 |
| Princeton BioMeditech BioSign H. pylori WB {OSOM H. pylori} ((for whole blood) |
| K980798 |
Helicobacter Pylori Antibodies |
General Immunology |
11/09/2009 |
| Arkray ReliOn Confirm Blood Glucose Monitoring System |
| K073416 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
10/30/2009 |
| Arkray, GLUCOCARD VITAL Blood Glucose Monitoring System |
| K091102 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
10/30/2009 |
| Nova Biomedical Corp. StatStrip Xpress Glucose Hosptial Meter |
| K070960 |
Glucose Monitoring Devices (Prescription Use Only) |
General Chemistry |
10/30/2009 |
| Acon Mission U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
10/28/2009 |
| Acon Mission U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
10/28/2009 |
| Acon Mission U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Blood |
Urinalysis |
10/28/2009 |
| Acon Mission U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
10/28/2009 |
| Acon Mission U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
10/28/2009 |
| Acon Mission U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
10/28/2009 |
| Acon Mission U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick pH |
Urinalysis |
10/28/2009 |
| Acon Mission U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Protein |
Urinalysis |
10/28/2009 |
| Acon Mission U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
10/28/2009 |
| Acon Mission U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
10/28/2009 |
| Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
10/28/2009 |
| Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
10/28/2009 |
| Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Blood |
Urinalysis |
10/28/2009 |
| Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
10/28/2009 |
| Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
10/28/2009 |
| Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
10/28/2009 |
| Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick pH |
Urinalysis |
10/28/2009 |
| Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Protein |
Urinalysis |
10/28/2009 |
| Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
10/28/2009 |
| Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
10/28/2009 |
| RefuAH U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
10/28/2009 |
| RefuAH U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
10/28/2009 |
| RefuAH U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Blood |
Urinalysis |
10/28/2009 |
| RefuAH U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
10/28/2009 |
| RefuAH U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
10/28/2009 |
| RefuAH U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
10/28/2009 |
| RefuAH U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick pH |
Urinalysis |
10/28/2009 |
| RefuAH U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Protein |
Urinalysis |
10/28/2009 |
| RefuAH U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
10/28/2009 |
| RefuAH U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
10/28/2009 |
| Genzyme Diagnostics OSOM ImmunoDip Urinary Albumin Test |
| K022538 |
Albumin, Urinary |
General Chemistry |
10/26/2009 |
| Fifty 50 Medical, Fifty 50 Glucose Monitoring System 2.0 |
| K083468 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
10/14/2009 |
| Major Biosystem Corp. AP-1000 Blood Glucose Monitoring System |
| K090389 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
10/14/2009 |
| Fora Care Inc. FORA G90 Blood Glucose Monitoring System |
| K091898 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
09/30/2009 |
| Fora Care Inc. U-Right TD-4234 Blood Glucose Monitoring System |
| K091898 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
09/30/2009 |
| UCP Biosciences, Inc. UCP Home Drug Screening Test Cards |
| K091588 |
Amphetamines |
Toxicology / TDM |
09/30/2009 |
| UCP Biosciences, Inc. UCP Home Drug Screening Test Cards |
| K091588 |
Cannabinoids (THC) |
Toxicology / TDM |
09/30/2009 |
| UCP Biosciences, Inc. UCP Home Drug Screening Test Cards |
| K091588 |
Phencyclidine (PCP) |
Toxicology / TDM |
09/30/2009 |
| UCP Biosciences, Inc. UCP Home Drug Screening Test Cards |
| K091588 |
Cocaine Metabolites |
Toxicology / TDM |
09/30/2009 |
| UCP Biosciences, Inc. UCP Home Drug Screening Test Cards |
| K091588 |
Opiates |
Toxicology / TDM |
09/30/2009 |
| UCP Biosciences, Inc. UCP Home Drug Screening Test Cards |
| K091588 |
Methadone |
Toxicology / TDM |
09/30/2009 |
| UCP Biosciences, Inc. UCP Home Drug Screening Test Cards |
| K091588 |
Methamphetamines |
Toxicology / TDM |
09/30/2009 |
| UCP Biosciences, Inc. UCP Home Drug Screening Test Cards |
| K091588 |
Benzodiazepines |
Toxicology / TDM |
09/30/2009 |
| UCP Biosciences, Inc. UCP Home Drug Screening Test Cards |
| K091588 |
Barbiturates |
Toxicology / TDM |
09/30/2009 |
| UCP Biosciences, Inc. UCP Home Drug Screening Test Cards |
| K091588 |
Morphine |
Toxicology / TDM |
09/30/2009 |
| UCP Biosciences, Inc. UCP Home Drug Screening Test Cards |
| K091588 |
Tricyclic Antidepressants |
Toxicology / TDM |
09/30/2009 |
| UCP Biosciences, Inc. UCP Home Drug Screening Test Cards |
| K091588 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
09/30/2009 |
| UCP Biosciences, Inc. UCP Home Drug Screening Test Cards |
| K091588 |
Oxycodone |
Toxicology / TDM |
09/30/2009 |
| UCP Biosciences, Inc. UCP Home Drug Screening Test Cups |
| K091588 |
Amphetamines |
Toxicology / TDM |
09/30/2009 |
| UCP Biosciences, Inc. UCP Home Drug Screening Test Cups |
| K091588 |
Cannabinoids (THC) |
Toxicology / TDM |
09/30/2009 |
| UCP Biosciences, Inc. UCP Home Drug Screening Test Cups |
| K091588 |
Phencyclidine (PCP) |
Toxicology / TDM |
09/30/2009 |
| UCP Biosciences, Inc. UCP Home Drug Screening Test Cups |
| K091588 |
Cocaine Metabolites |
Toxicology / TDM |
09/30/2009 |
| UCP Biosciences, Inc. UCP Home Drug Screening Test Cups |
| K091588 |
Opiates |
Toxicology / TDM |
09/30/2009 |
| UCP Biosciences, Inc. UCP Home Drug Screening Test Cups |
| K091588 |
Methadone |
Toxicology / TDM |
09/30/2009 |
| UCP Biosciences, Inc. UCP Home Drug Screening Test Cups |
| K091588 |
Methamphetamines |
Toxicology / TDM |
09/30/2009 |
| UCP Biosciences, Inc. UCP Home Drug Screening Test Cups |
| K091588 |
Benzodiazepines |
Toxicology / TDM |
09/30/2009 |
| UCP Biosciences, Inc. UCP Home Drug Screening Test Cups |
| K091588 |
Barbiturates |
Toxicology / TDM |
09/30/2009 |
| UCP Biosciences, Inc. UCP Home Drug Screening Test Cups |
| K091588 |
Morphine |
Toxicology / TDM |
09/30/2009 |
| UCP Biosciences, Inc. UCP Home Drug Screening Test Cups |
| K091588 |
Tricyclic Antidepressants |
Toxicology / TDM |
09/30/2009 |
| UCP Biosciences, Inc. UCP Home Drug Screening Test Cups |
| K091588 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
09/30/2009 |
| UCP Biosciences, Inc. UCP Home Drug Screening Test Cups |
| K091588 |
Oxycodone |
Toxicology / TDM |
09/30/2009 |
| CLIA waived inc Rapid STREP A Test |
| K023270 |
Streptococcus, Group A |
Bacteriology |
09/15/2009 |
| Fora Care Inc. U-Right TD-4250 Blood Glucose Monitoring System |
| K083570 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
09/14/2009 |
| Fora Care Inc. U-Right TD-4249 Blood Glucose Monitoring System |
| K083570 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
09/14/2009 |
| Siemens Clinitek 50 Urine Chemistry Analyzer |
| K960546 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
09/14/2009 |
| Siemens Clinitek 50 Urine Chemistry Analyzer |
| K960546 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
09/14/2009 |
| Siemens Clinitek 50 Urine Chemistry Analyzer |
| K960546 |
Urine Qualitative Dipstick Blood |
Urinalysis |
09/14/2009 |
| Siemens Clinitek 50 Urine Chemistry Analyzer |
| K960546 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
09/14/2009 |
| Siemens Clinitek 50 Urine Chemistry Analyzer |
| K960546 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
09/14/2009 |
| Siemens Clinitek 50 Urine Chemistry Analyzer |
| K960546 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
09/14/2009 |
| Siemens Clinitek 50 Urine Chemistry Analyzer |
| K960546 |
Urine Qualitative Dipstick pH |
Urinalysis |
09/14/2009 |
| Siemens Clinitek 50 Urine Chemistry Analyzer |
| K960546 |
Urine Qualitative Dipstick Protein |
Urinalysis |
09/14/2009 |
| Siemens Clinitek 50 Urine Chemistry Analyzer |
| K960546 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
09/14/2009 |
| Siemens Clinitek 50 Urine Chemistry Analyzer |
| K960546 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
09/14/2009 |
| Siemens Clinitek 50 Urine Chemistry Analyzer |
| K972706 |
Microalbumin |
General Chemistry |
09/14/2009 |
| Siemens Clinitek 50 Urine Chemistry Analyzer |
| K972706 |
Creatinine |
General Chemistry |
09/14/2009 |
| Bayer Contour USB Glucose Monitoring System |
| K091820 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
09/09/2009 |
| Excel Medical Group Bio View hCG Pregnancy Serum/Urine Cassette and Dipstick Tests |
| K071030 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
09/09/2009 |
| GERMAINE LABORATORIES AimStep Immunological Fecal Occult Blood Test (iFOBT) |
| K063693 |
Fecal Occult Blood |
General Chemistry |
09/09/2009 |
| PSS CONSULT Diagnostic Occult Blood Test |
| K911075 |
Fecal Occult Blood |
General Chemistry |
09/09/2009 |
| PSS CONSULT diagnostics Occult Blood Test-ES |
| K003359 |
Fecal Occult Blood |
General Chemistry |
09/09/2009 |
| SCI International, Inc. Baby Test Pregnancy Test Cassette Format |
| K050741 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
09/09/2009 |
| SCI International, Inc. U-Check Pregnancy Test Cassette Format |
| K050741 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
09/09/2009 |
| Specialty Medical Supplies Vocal Point Blood Glucose Monitoring System |
| K083570 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
09/09/2009 |
| Wiener Laboratories Urine Strip |
| K083724 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
09/09/2009 |
| Wiener Laboratories Urine Strip |
| K083724 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
09/09/2009 |
| Wiener Laboratories Urine Strip |
| K083724 |
Urine Qualitative Dipstick Blood |
Urinalysis |
09/09/2009 |
| Wiener Laboratories Urine Strip |
| K083724 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
09/09/2009 |
| Wiener Laboratories Urine Strip |
| K083724 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
09/09/2009 |
| Wiener Laboratories Urine Strip |
| K083724 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
09/09/2009 |
| Wiener Laboratories Urine Strip |
| K083724 |
Urine Qualitative Dipstick pH |
Urinalysis |
09/09/2009 |
| Wiener Laboratories Urine Strip |
| K083724 |
Urine Qualitative Dipstick Protein |
Urinalysis |
09/09/2009 |
| Wiener Laboratories Urine Strip |
| K083724 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
09/09/2009 |
| Wiener Laboratories Urine Strip |
| K083724 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
09/09/2009 |
| Wiener Laboratories Urine Strip |
| K083724 |
Urine Qualitative Dipstick Ascorbic Acid |
Urinalysis |
09/09/2009 |
| Guangzhou Wondfo Biotech One Step HCG Urine/Serum Test |
| K072500 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
09/03/2009 |
| Arkray USA Inc. Assure Pro Blood Glucose Monitoring System |
| K090332 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
09/01/2009 |
| EPS Bio Technology Corp. EasyPlus mini R13N Self-Monitoring Blood Glucose System |
| K091481 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
09/01/2009 |
| Omnis Health Embrace No Code Blood Glucose Monitoring System |
| K090043 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
09/01/2009 |
| Sacks Medical Corp., RefuAH Plus Blood Glucose Monitoring System |
| K090057 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
09/01/2009 |
| Sacks Medical Corporation RefuAH Urinalysis Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
08/24/2009 |
| Sacks Medical Corporation RefuAH Urinalysis Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
08/24/2009 |
| Sacks Medical Corporation RefuAH Urinalysis Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Blood |
Urinalysis |
08/24/2009 |
| Sacks Medical Corporation RefuAH Urinalysis Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
08/24/2009 |
| Sacks Medical Corporation RefuAH Urinalysis Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
08/24/2009 |
| Sacks Medical Corporation RefuAH Urinalysis Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
08/24/2009 |
| Sacks Medical Corporation RefuAH Urinalysis Reagent Strips |
| K061559 |
Urine Qualitative Dipstick pH |
Urinalysis |
08/24/2009 |
| Sacks Medical Corporation RefuAH Urinalysis Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Protein |
Urinalysis |
08/24/2009 |
| Sacks Medical Corporation RefuAH Urinalysis Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
08/24/2009 |
| Sacks Medical Corporation RefuAH Urinalysis Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
08/24/2009 |
| Sacks Medical Corporation RefuAH Urinalysis Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Ascorbic Acid |
Urinalysis |
08/24/2009 |
| BinaxNOW Influenza A & B Test |
| K092223 |
Influenza A/B |
Virology |
08/18/2009 |
| Diagnostic Test Group, Clarity Plus Blood Glucose Monitoring System |
| K090057 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
08/07/2009 |
| Pro-Advantage by NDC H. Pylori Device {Whole Blood} |
| K024350 |
Helicobacter Pylori Antibodies |
General Immunology |
08/07/2009 |
| Fora Care Inc. U-RIGHT TD-4227 No Coding Blood Glucose Monitoring System |
| K090188 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
07/16/2009 |
| Fora Care Inc., FORA V12 Blood Glucose Monitoring System |
| K090404 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
07/16/2009 |
| Fora Care, Inc., FORA V10 Blood Glucose Monitoring System |
| K090404 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
07/16/2009 |
| ProAdvantage by NDC Infectious Mononucleosis Test Device (Whole Blood Only) |
| K042272 |
Infectious Mononucleosis Antibodies (Mono) |
General Immunology |
07/16/2009 |
| U.S. Diagnostics Inc. ACURA Blood Glucose Monitoring System |
| K083468 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
07/16/2009 |
| BTNX Inc. Rapid Response hCG Pregnancy Serum/Urine Test Strip |
| K974060 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
07/01/2009 |
| Inverness Medical Innovations Signify ER Drug Screen |
| K041685 |
Amphetamines |
Toxicology / TDM |
07/01/2009 |
| Inverness Medical Innovations Signify ER Drug Screen |
| K041685 |
Cannabinoids (THC) |
Toxicology / TDM |
07/01/2009 |
| Inverness Medical Innovations Signify ER Drug Screen |
| K041685 |
Phencyclidine (PCP) |
Toxicology / TDM |
07/01/2009 |
| Inverness Medical Innovations Signify ER Drug Screen |
| K041685 |
Cocaine Metabolites |
Toxicology / TDM |
07/01/2009 |
| Inverness Medical Innovations Signify ER Drug Screen |
| K041685 |
Opiates |
Toxicology / TDM |
07/01/2009 |
| Inverness Medical Innovations Signify ER Drug Screen |
| K041685 |
Propoxyphene |
Toxicology / TDM |
07/01/2009 |
| Inverness Medical Innovations Signify ER Drug Screen |
| K041685 |
Benzodiazepines |
Toxicology / TDM |
07/01/2009 |
| Inverness Medical Innovations Signify ER Drug Screen |
| K041685 |
Barbiturates |
Toxicology / TDM |
07/01/2009 |
| Inverness Medical Innovations Signify ER Drug Screen |
| K041685 |
Tricyclic Antidepressants |
Toxicology / TDM |
07/01/2009 |
| Inverness Medical Innovations Signify ER Drug Screen |
| K041685 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
07/01/2009 |
| Inverness Medical Innovations Signify ER Drug Screen |
| K041685 |
Oxycodone |
Toxicology / TDM |
07/01/2009 |
| Inverness Medical Innovations Signify hCG Urine Dipstick |
| K993203 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
07/01/2009 |
| National Distribution and Contracting Inc., Pro Advantage by NDC Urine/Serum Pregnancy Cassette Device |
| K993065 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
07/01/2009 |
| Turklab Rapidan Optima Early Test One Step hCG Urine Pregnancy Test for Home Use |
| K081150 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
07/01/2009 |
| Turklab Toyo Diagnostics One Step hCG Urine Pregnancy Cassette Test |
| K081150 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
07/01/2009 |
| Turklab Toyo Diagnostics One Step hCG Urine Pregnancy Strip Test for Home Use |
| K081150 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
07/01/2009 |
| All Medicus Gluco Dr. Plus+ Blood Glucose Monitoring System |
| K082328 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/12/2009 |
| Early Detect Inc., EarlyDETECT Pro hCG Urine pregnancy test card |
| K020968 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
06/12/2009 |
| Early Detect Inc., EarlyDETECT Pro hCG Urine pregnancy test strip |
| K020968 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
06/12/2009 |
| Fora Care FORA V22 Blood Glucose Monitoring System |
| K081609 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/12/2009 |
| Fora Care Inc. U-Right TD-4225 Blood Glucose Monitoring System |
| K073494 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/12/2009 |
| Stanbio HemoPoint H2 DM Hemoglobin Measurement System {with Data Management} |
| K090093 |
Hemoglobin |
Hematology |
06/12/2009 |
| Diagnostic Devices Prodigy AutoCode Talking Blood Glucose Monitoring System |
| K073118 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/08/2009 |
| Diagnostic Devices Prodigy Pocket Blood Glucose Monitoring System |
| K073118 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/08/2009 |
| Diagnostic Devices Prodigy Voice Talking Blood Glucose Monitoring System |
| K073118 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/08/2009 |
| National Distribution and Contracting Inc., Pro Advantage by NDC Urine Pregnancy Cassette Device |
| K993317 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
06/08/2009 |
| Tyson Bioresearch Inc. Diachex+ Pro Blood Glucose Monitoring System |
| K090629 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/08/2009 |
| Tyson Bioresearch Inc. Easy Step Blood Glucose Monitoring System |
| K090629 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/08/2009 |
| Abbott OptiumEZ Blood Glucose Monitoring System |
| K081975 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/03/2009 |
| CLIAwaived INC. Thyroid Test Rapid TSH Cassette (Whole Blood) |
| K990658 |
Thyroid Stimulating Hormone (TSH) |
Endocrinology |
06/03/2009 |
| Fora Care Inc. FORA V10 Blood Glucose Monitoring System |
| K081715 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/03/2009 |
| Fora Care Inc. FORA G30 Blood Glucose Monitoring System |
| K090187 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
05/29/2009 |
| EarlyDETECT H. PYLORI WHOLE BLOOD RAPID TEST |
| K024360 |
Helicobacter Pylori |
Bacteriology |
05/21/2009 |
| IMI Signify Strep A Dipstick {Inverness Medical Innovations} |
| K010582 |
Streptococcus, Group A |
Bacteriology |
05/21/2009 |
| Inverness Medical SIGNIFY H. PYLORI WHOLE BLOOD |
| K024350 |
Helicobacter Pylori Antibodies |
General Immunology |
05/21/2009 |
| Inverness Medical Signify Strep A Cassette {Inverness Medical Innovations} |
| K031784 |
Streptococcus, Group A |
Bacteriology |
05/21/2009 |
| Twin Spirit, Inc. DrugSmart Cup |
| K082898 |
Amphetamines |
Toxicology / TDM |
05/11/2009 |
| Twin Spirit, Inc. DrugSmart Cup |
| K082898 |
Cannabinoids (THC) |
Toxicology / TDM |
05/11/2009 |
| Twin Spirit, Inc. DrugSmart Cup |
| K082898 |
Phencyclidine (PCP) |
Toxicology / TDM |
05/11/2009 |
| Twin Spirit, Inc. DrugSmart Cup |
| K082898 |
Cocaine Metabolites |
Toxicology / TDM |
05/11/2009 |
| Twin Spirit, Inc. DrugSmart Cup |
| K082898 |
Opiates |
Toxicology / TDM |
05/11/2009 |
| Twin Spirit, Inc. DrugSmart Cup |
| K082898 |
Methadone |
Toxicology / TDM |
05/11/2009 |
| Twin Spirit, Inc. DrugSmart Cup |
| K082898 |
Methamphetamines |
Toxicology / TDM |
05/11/2009 |
| Twin Spirit, Inc. DrugSmart Cup |
| K082898 |
Benzodiazepines |
Toxicology / TDM |
05/11/2009 |
| Twin Spirit, Inc. DrugSmart Cup |
| K082898 |
Barbiturates |
Toxicology / TDM |
05/11/2009 |
| Twin Spirit, Inc. DrugSmart Cup |
| K082898 |
Tricyclic Antidepressants |
Toxicology / TDM |
05/11/2009 |
| Twin Spirit, Inc. DrugSmart Cup |
| K082898 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
05/11/2009 |
| Twin Spirit, Inc. DrugSmart Cup |
| K082898 |
Oxycodone |
Toxicology / TDM |
05/11/2009 |
| All Medicus GlucoDr auto Blood Glucose Test System |
| K083628 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
05/07/2009 |
| 1 Step Detect Associates DTX Drug Test Cup Integrated E-Z- Split Key Cup II |
| K050878 |
Amphetamines |
Toxicology / TDM |
04/30/2009 |
| 1 Step Detect Associates DTX Drug Test Cup Integrated E-Z- Split Key Cup II |
| K050878 |
Cannabinoids (THC) |
Toxicology / TDM |
04/30/2009 |
| 1 Step Detect Associates DTX Drug Test Cup Integrated E-Z- Split Key Cup II |
| K050878 |
Phencyclidine (PCP) |
Toxicology / TDM |
04/30/2009 |
| 1 Step Detect Associates DTX Drug Test Cup Integrated E-Z- Split Key Cup II |
| K050878 |
Cocaine Metabolites |
Toxicology / TDM |
04/30/2009 |
| 1 Step Detect Associates DTX Drug Test Cup Integrated E-Z- Split Key Cup II |
| K050878 |
Opiates |
Toxicology / TDM |
04/30/2009 |
| 1 Step Detect Associates DTX Drug Test Cup Integrated E-Z- Split Key Cup II |
| K050878 |
Methamphetamine/Amphetamine |
Toxicology / TDM |
04/30/2009 |
| 1 Step Detect Associates DTX Drug Test Cup Integrated E-Z- Split Key Cup II |
| K050878 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
04/30/2009 |
| Acon Laboratories, On-Call Plus Blood Glucose Monitoring System |
| K090057 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
04/30/2009 |
| BTNX Inc. Rapid Response hCG Pregnancy Test (Midstream) |
| K974059 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
04/30/2009 |
| Home Diagnostics, TRUEbalance Blood Glucose Monitoring System |
| K090495 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
04/30/2009 |
| Inverness Medical Innovations Signify hCG Combo Cassette |
| K993065 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
04/30/2009 |
| The Kroger Co. Kroger Blood Glucose Monitoring System |
| K073573 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
04/30/2009 |
| Abbott ReliOn Ultima Blood Glucose Monitoring System |
| K083223 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
04/22/2009 |
| AgaMatrix WaveSense Presto Pro Blood Glucose Monitoring System |
| K073573 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
04/22/2009 |
| National Diagnostic Products Betachek Blood Glucose (Sugar) Test |
| K062187 |
Whole Blood Qualitative Dipstick Glucose |
General Chemistry |
04/22/2009 |
| Fora Care Inc. FORA V12 No-Coding Blood Glucose Monitoring System |
| K090536 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
04/16/2009 |
| Acceava Mono II (Whole Blood) |
| K042272 |
Infectious Mononucleosis Antibodies (Mono) |
General Immunology |
04/14/2009 |
| CLIAwaived Inc. Pregnancy Combo Test (Cassette) |
| K984077 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
04/06/2009 |
| CLIAwaived Inc. Pregnancy Combo Test (Dip-Strip) |
| K984080 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
04/06/2009 |
| Acceava Strep A Twist Rapid Test {Streptococcus, Group A} |
| K010582 |
Streptococcus, Group A |
Bacteriology |
04/01/2009 |
| Consult Diagnostics STREP A RAPID Dipstick {Streptococcuc, Group A} |
| K010582 |
Streptococcus, Group A |
Bacteriology |
04/01/2009 |
| MEC Dynamics Avie A1c Test System |
| K081269 |
Glycosylated Hemoglobin (Hgb A1c) |
General Chemistry |
04/01/2009 |
| Amerifit Inc Azo Test Strips Urinary Tract Infection Test |
| K063295 |
Nitrite, Urine |
General Chemistry |
03/16/2009 |
| Amerifit Inc Azo Test Strips Urinary Tract Infection Test |
| K063295 |
Leukocyte Esterase, Urinary |
Urinalysis |
03/16/2009 |
| BTNX Inc. Rapid Response hCG Pregnancy Test Cassette Format |
| K050741 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
03/16/2009 |
| BTNX Inc. Rapid Response Pregnancy Test Strip Format |
| K951705 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
03/16/2009 |
| Lil' Drug Store Products Inc. Vagi-Screen Vaginal Health Test |
| X080117 |
pH |
General Chemistry |
03/16/2009 |
| MACHEREY-NAGEL Medi-Test Glucose |
| K991927 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
03/16/2009 |
| Innovacon, Inc. One Step hCG Single Test Card |
| K993203 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
03/12/2009 |
| PSS World Medical, Inc. Consult Diagnostics hCG Combo Cassette |
| K993065 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
03/12/2009 |
| Amedica Biotech Amedica Drug Screen Test Cup |
| K082898 |
Amphetamines |
Toxicology / TDM |
03/10/2009 |
| Amedica Biotech Amedica Drug Screen Test Cup |
| K082898 |
Cannabinoids (THC) |
Toxicology / TDM |
03/10/2009 |
| Amedica Biotech Amedica Drug Screen Test Cup |
| K082898 |
Phencyclidine (PCP) |
Toxicology / TDM |
03/10/2009 |
| Amedica Biotech Amedica Drug Screen Test Cup |
| K082898 |
Cocaine Metabolites |
Toxicology / TDM |
03/10/2009 |
| Amedica Biotech Amedica Drug Screen Test Cup |
| K082898 |
Opiates |
Toxicology / TDM |
03/10/2009 |
| Amedica Biotech Amedica Drug Screen Test Cup |
| K082898 |
Methadone |
Toxicology / TDM |
03/10/2009 |
| Amedica Biotech Amedica Drug Screen Test Cup |
| K082898 |
Methamphetamines |
Toxicology / TDM |
03/10/2009 |
| Amedica Biotech Amedica Drug Screen Test Cup |
| K082898 |
Benzodiazepines |
Toxicology / TDM |
03/10/2009 |
| Amedica Biotech Amedica Drug Screen Test Cup |
| K082898 |
Barbiturates |
Toxicology / TDM |
03/10/2009 |
| Amedica Biotech Amedica Drug Screen Test Cup |
| K082898 |
Tricyclic Antidepressants |
Toxicology / TDM |
03/10/2009 |
| Amedica Biotech Amedica Drug Screen Test Cup |
| K082898 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
03/10/2009 |
| Amedica Biotech Amedica Drug Screen Test Cup |
| K082898 |
Oxycodone |
Toxicology / TDM |
03/10/2009 |
| EarlyDetect Pro Influenza A Test |
| K041441 |
Influenza A |
Virology |
03/10/2009 |
| EarlyDetect Pro Influenza B Test |
| K041439 |
Influenza B |
Virology |
03/10/2009 |
| PSS World Medical, Inc. Consult Diagnostics hCG Dipstick |
| K993203 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
03/10/2009 |
| PSS World Medical, Inc. Consult Diagnostics hCG Urine Cassette |
| K993317 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
03/10/2009 |
| Henry Schein OneStep+ iFOBT |
| K060463 |
Fecal Occult Blood |
General Chemistry |
03/05/2009 |
| lifeSign Status-COLON ASSURE Guaiac Test |
| K902360 |
Fecal Occult Blood |
General Chemistry |
03/05/2009 |
| Siemens Clinitek Status Urine Chemistry Analyzer |
| K031947 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
03/05/2009 |
| Siemens Clinitek Status Urine Chemistry Analyzer |
| K031947 |
Microalbumin |
General Chemistry |
03/05/2009 |
| Siemens Clinitek Status Urine Chemistry Analyzer |
| K031947 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
03/05/2009 |
| Siemens Clinitek Status Urine Chemistry Analyzer |
| K031947 |
Urine Qualitative Dipstick Blood |
Urinalysis |
03/05/2009 |
| Siemens Clinitek Status Urine Chemistry Analyzer |
| K031947 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
03/05/2009 |
| Siemens Clinitek Status Urine Chemistry Analyzer |
| K031947 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
03/05/2009 |
| Siemens Clinitek Status Urine Chemistry Analyzer |
| K031947 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
03/05/2009 |
| Siemens Clinitek Status Urine Chemistry Analyzer |
| K031947 |
Urine Qualitative Dipstick pH |
Urinalysis |
03/05/2009 |
| Siemens Clinitek Status Urine Chemistry Analyzer |
| K031947 |
Urine Qualitative Dipstick Protein |
Urinalysis |
03/05/2009 |
| Siemens Clinitek Status Urine Chemistry Analyzer |
| K031947 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
03/05/2009 |
| Siemens Clinitek Status Urine Chemistry Analyzer |
| K031947 |
Urine Qualitative Dipstick Creatinine |
Urinalysis |
03/05/2009 |
| US Diagnostics, Inc. Infinity Blood Glucose Monitoring System |
| K082201 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
02/25/2009 |
| Home Diagnostics GRACEtrack Blood Glucose Monitoring System |
| K032657 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
02/18/2009 |
| InfopiaUSA, LLC Duo-Max Blood Pressure and Glucose Monitoring System, Model HMF-100 |
| K080636 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
02/18/2009 |
| i-SENS, Inc. CareSens N Blood Glucose Monitoring System |
| K083468 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
02/12/2009 |
| Fora Care Inc. FORA TD-4251 Blood Glucose Monitoring System |
| K082482 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
02/03/2009 |
| Fora Care Inc. U-Right TD-4252A Blood Glucose Monitoring System |
| K082482 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
02/03/2009 |
| Fora Care Inc. U-Right TD-4252B Blood Glucose Monitoring System |
| K082482 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
02/03/2009 |
| Fora Care Inc. U-Right TD-4254 Blood Glucose Monitoring System |
| K082482 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
02/03/2009 |
| AgaMatrix WaveSense AMP Blood Glucose Monitoring System |
| K073573 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
02/02/2009 |
| Roche Diagnostics Accutrend Plus System (fingerstick whole blood) |
| K051376 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
01/29/2009 |
| Roche Diagnostics Accutrend Plus System (fingerstick whole blood) |
| K051376 |
Cholesterol |
General Chemistry |
01/29/2009 |
| EPS Bio Technology Corp. EasyPlus mini R2N Self-Monitoring Blood Glucose Test System |
| K081796 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
01/27/2009 |
| EPS Bio Technology EasyMax N Self Monitoring Blood Glucose Test System |
| K083099 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
01/27/2009 |
| BTNX Rapid Response hCG Pregnancy Urine Cassette and Dipstick Tests |
| K070921 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
01/26/2009 |
| IM Diagnostics, Inc. IM Confirms II hCG Pregnancy Urine Cassette and Dipstick Tests |
| K070921 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
01/26/2009 |
| Siemens Clinitek Status Urine Chemistry Analyzer |
| K032563 |
hCG, Urine |
Endocrinology |
01/26/2009 |
| Card Guard Scientific Survival, Ltd. PMP4 Easy2Check Personal Wireless Blood Pressure and Blood Glucose Monitoring System |
| K082521 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
01/22/2009 |
| Cliawaived, Inc. CLIAWAIVED H. PYLORI WHOLE BLOOD RAPID TEST |
| K024360 |
Helicobacter Pylori Antibodies |
General Immunology |
01/22/2009 |
| Conception Technologies hCG One Step Pregnancy Test Device (urine) |
| K993317 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
01/22/2009 |
| Infopia USA Envision Autocode Blood Glucose Monitoring System |
| K082020 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
01/15/2009 |
| Fora Care Inc. FORA TD-4245 Blood Glucose Monitoring System |
| K083664 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
01/12/2009 |
| Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis |
| K061559 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
01/09/2009 |
| Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis |
| K061559 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
01/09/2009 |
| Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis |
| K061559 |
Urine Qualitative Dipstick Blood |
Urinalysis |
01/09/2009 |
| Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis |
| K061559 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
01/09/2009 |
| Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis |
| K061559 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
01/09/2009 |
| Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis |
| K061559 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
01/09/2009 |
| Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis |
| K061559 |
Urine Qualitative Dipstick pH |
Urinalysis |
01/09/2009 |
| Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis |
| K061559 |
Urine Qualitative Dipstick Protein |
Urinalysis |
01/09/2009 |
| Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis |
| K061559 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
01/09/2009 |
| Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis |
| K061559 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
01/09/2009 |
| Entra Health Systems, Ltd., MyGlucoHealth Glucose Monitoring System |
| K081703 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
01/09/2009 |
| Aventir Biotech LLC Home Check Multiple Drug Cup Test (Professional version) |
| K071489 |
Amphetamines |
Toxicology / TDM |
01/07/2009 |
| Aventir Biotech LLC Home Check Multiple Drug Cup Test (Professional version) |
| K071489 |
Phencyclidine (PCP) |
Toxicology / TDM |
01/07/2009 |
| Aventir Biotech LLC Home Check Multiple Drug Cup Test (Professional version) |
| K071489 |
Cocaine Metabolites |
Toxicology / TDM |
01/07/2009 |
| Aventir Biotech LLC Home Check Multiple Drug Cup Test (Professional version) |
| K071489 |
Methadone |
Toxicology / TDM |
01/07/2009 |
| Aventir Biotech LLC Home Check Multiple Drug Cup Test (Professional version) |
| K071489 |
Methamphetamines |
Toxicology / TDM |
01/07/2009 |
| Aventir Biotech LLC Home Check Multiple Drug Cup Test (Professional version) |
| K071489 |
Benzodiazepines |
Toxicology / TDM |
01/07/2009 |
| Aventir Biotech LLC Home Check Multiple Drug Cup Test (Professional version) |
| K071489 |
Barbiturates |
Toxicology / TDM |
01/07/2009 |
| Aventir Biotech LLC Home Check Multiple Drug Cup Test (Professional version) |
| K071489 |
Morphine |
Toxicology / TDM |
01/07/2009 |
| Aventir Biotech LLC Home Check Multiple Drug Cup Test (Professional version) |
| K071489 |
Tricyclic Antidepressants |
Toxicology / TDM |
01/07/2009 |
| Aventir Biotech LLC Home Check Multiple Drug Cup Test (Professional version) |
| K071489 |
Oxycodone |
Toxicology / TDM |
01/07/2009 |
| Avnetir Biotech LLC Home Check Multiple Drug Cup Test (Professional version) |
| K071489 |
Cannabinoids (THC) |
Toxicology / TDM |
01/07/2009 |
| Clia Waived.com CLIA-X Mulitple Drug Cup Test (Professional version) |
| K071489 |
Amphetamines |
Toxicology / TDM |
01/07/2009 |
| Clia Waived.com CLIA-X Mulitple Drug Cup Test (Professional version) |
| K071489 |
Cannabinoids (THC) |
Toxicology / TDM |
01/07/2009 |
| Clia Waived.com CLIA-X Mulitple Drug Cup Test (Professional version) |
| K071489 |
Phencyclidine (PCP) |
Toxicology / TDM |
01/07/2009 |
| Clia Waived.com CLIA-X Mulitple Drug Cup Test (Professional version) |
| K071489 |
Cocaine Metabolites |
Toxicology / TDM |
01/07/2009 |
| Clia Waived.com CLIA-X Mulitple Drug Cup Test (Professional version) |
| K071489 |
Methadone |
Toxicology / TDM |
01/07/2009 |
| Clia Waived.com CLIA-X Mulitple Drug Cup Test (Professional version) |
| K071489 |
Methamphetamines |
Toxicology / TDM |
01/07/2009 |
| Clia Waived.com CLIA-X Mulitple Drug Cup Test (Professional version) |
| K071489 |
Benzodiazepines |
Toxicology / TDM |
01/07/2009 |
| Clia Waived.com CLIA-X Mulitple Drug Cup Test (Professional version) |
| K071489 |
Barbiturates |
Toxicology / TDM |
01/07/2009 |
| Clia Waived.com CLIA-X Mulitple Drug Cup Test (Professional version) |
| K071489 |
Morphine |
Toxicology / TDM |
01/07/2009 |
| Clia Waived.com CLIA-X Mulitple Drug Cup Test (Professional version) |
| K071489 |
Tricyclic Antidepressants |
Toxicology / TDM |
01/07/2009 |
| Clia Waived.com CLIA-X Mulitple Drug Cup Test (Professional version) |
| K071489 |
Oxycodone |
Toxicology / TDM |
01/07/2009 |
| Syntron Bioresearch Quikscreen Multiple Drug Cup Test (Professional version) |
| K071489 |
Amphetamines |
Toxicology / TDM |
01/07/2009 |
| Syntron Bioresearch Quikscreen Multiple Drug Cup Test (Professional version) |
| K071489 |
Cannabinoids (THC) |
Toxicology / TDM |
01/07/2009 |
| Syntron Bioresearch Quikscreen Multiple Drug Cup Test (Professional version) |
| K071489 |
Phencyclidine (PCP) |
Toxicology / TDM |
01/07/2009 |
| Syntron Bioresearch Quikscreen Multiple Drug Cup Test (Professional version) |
| K071489 |
Cocaine Metabolites |
Toxicology / TDM |
01/07/2009 |
| Syntron Bioresearch Quikscreen Multiple Drug Cup Test (Professional version) |
| K071489 |
Methadone |
Toxicology / TDM |
01/07/2009 |
| Syntron Bioresearch Quikscreen Multiple Drug Cup Test (Professional version) |
| K071489 |
Methamphetamines |
Toxicology / TDM |
01/07/2009 |
| Syntron Bioresearch Quikscreen Multiple Drug Cup Test (Professional version) |
| K071489 |
Benzodiazepines |
Toxicology / TDM |
01/07/2009 |
| Syntron Bioresearch Quikscreen Multiple Drug Cup Test (Professional version) |
| K071489 |
Barbiturates |
Toxicology / TDM |
01/07/2009 |
| Syntron Bioresearch Quikscreen Multiple Drug Cup Test (Professional version) |
| K071489 |
Morphine |
Toxicology / TDM |
01/07/2009 |
| Syntron Bioresearch Quikscreen Multiple Drug Cup Test (Professional version) |
| K071489 |
Tricyclic Antidepressants |
Toxicology / TDM |
01/07/2009 |
| Syntron Bioresearch Quikscreen Multiple Drug Cup Test (Professional version) |
| K071489 |
Oxycodone |
Toxicology / TDM |
01/07/2009 |
| Amedica Biotech The Amedica Home Drug Test Cup |
| K082898 |
Amphetamines |
Toxicology / TDM |
01/05/2009 |
| Amedica Biotech The Amedica Home Drug Test Cup |
| K082898 |
Cannabinoids (THC) |
Toxicology / TDM |
01/05/2009 |
| Amedica Biotech The Amedica Home Drug Test Cup |
| K082898 |
Phencyclidine (PCP) |
Toxicology / TDM |
01/05/2009 |
| Amedica Biotech The Amedica Home Drug Test Cup |
| K082898 |
Cocaine Metabolites |
Toxicology / TDM |
01/05/2009 |
| Amedica Biotech The Amedica Home Drug Test Cup |
| K082898 |
Opiates |
Toxicology / TDM |
01/05/2009 |
| Amedica Biotech The Amedica Home Drug Test Cup |
| K082898 |
Methadone |
Toxicology / TDM |
01/05/2009 |
| Amedica Biotech The Amedica Home Drug Test Cup |
| K082898 |
Methamphetamines |
Toxicology / TDM |
01/05/2009 |
| Amedica Biotech The Amedica Home Drug Test Cup |
| K082898 |
Benzodiazepines |
Toxicology / TDM |
01/05/2009 |
| Amedica Biotech The Amedica Home Drug Test Cup |
| K082898 |
Barbiturates |
Toxicology / TDM |
01/05/2009 |
| Amedica Biotech The Amedica Home Drug Test Cup |
| K082898 |
Tricyclic Antidepressants |
Toxicology / TDM |
01/05/2009 |
| Amedica Biotech The Amedica Home Drug Test Cup |
| K082898 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
01/05/2009 |
| Amedica Biotech The Amedica Home Drug Test Cup |
| K082898 |
Oxycodone |
Toxicology / TDM |
01/05/2009 |
| BTNX Inc. Rapid Response hCG Pregnancy Serum/Urine Test Cassette and Dipstick Tests |
| K071030 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
01/05/2009 |
| BTNX Inc. Rapid Response hCG Pregnancy Test 2000 mIU/mL |
| K052694 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
01/05/2009 |
| CLIAwaived Inc. Pregnancy Urine Test (Dip-strip) |
| K984079 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
01/05/2009 |
| CLIAwaived, Inc. Pregnancy Urine Test (Cassette) |
| K984076 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
01/05/2009 |
| Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis |
| K970250 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
01/05/2009 |
| Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis |
| K970250 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
01/05/2009 |
| Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis |
| K970250 |
Urine Qualitative Dipstick Blood |
Urinalysis |
01/05/2009 |
| Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis |
| K970250 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
01/05/2009 |
| Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis |
| K970250 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
01/05/2009 |
| Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis |
| K970250 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
01/05/2009 |
| Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis |
| K970250 |
Urine Qualitative Dipstick pH |
Urinalysis |
01/05/2009 |
| Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis |
| K970250 |
Urine Qualitative Dipstick Protein |
Urinalysis |
01/05/2009 |
| Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis |
| K970250 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
01/05/2009 |
| Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis |
| K970250 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
01/05/2009 |
| Fora Care Inc. FORA D15c Blood Glucose Plus Pressure Monitoring System |
| K062800 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
01/05/2009 |
| Fora Care Inc. FORA TD-4244 Blood Glucose Monitoring System |
| K081715 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
01/05/2009 |
| Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips |
| K991927 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
01/05/2009 |
| Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips |
| K991927 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
01/05/2009 |
| Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips |
| K991927 |
Urine Qualitative Dipstick Blood |
Urinalysis |
01/05/2009 |
| Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips |
| K991927 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
01/05/2009 |
| Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips |
| K991927 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
01/05/2009 |
| Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips |
| K991927 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
01/05/2009 |
| Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips |
| K991927 |
Urine Qualitative Dipstick pH |
Urinalysis |
01/05/2009 |
| Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips |
| K991927 |
Urine Qualitative Dipstick Protein |
Urinalysis |
01/05/2009 |
| Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips |
| K991927 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
01/05/2009 |
| Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips |
| K991927 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
01/05/2009 |
| Jant Pharmacal Corporation Accustrip URS Reader |
| K061742 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
01/05/2009 |
| Jant Pharmacal Corporation Accustrip URS Reader |
| K061742 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
01/05/2009 |
| Jant Pharmacal Corporation Accustrip URS Reader |
| K061742 |
Urine Qualitative Dipstick Blood |
Urinalysis |
01/05/2009 |
| Jant Pharmacal Corporation Accustrip URS Reader |
| K061742 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
01/05/2009 |
| Jant Pharmacal Corporation Accustrip URS Reader |
| K061742 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
01/05/2009 |
| Jant Pharmacal Corporation Accustrip URS Reader |
| K061742 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
01/05/2009 |
| Jant Pharmacal Corporation Accustrip URS Reader |
| K061742 |
Urine Qualitative Dipstick pH |
Urinalysis |
01/05/2009 |
| Jant Pharmacal Corporation Accustrip URS Reader |
| K061742 |
Urine Qualitative Dipstick Protein |
Urinalysis |
01/05/2009 |
| Jant Pharmacal Corporation Accustrip URS Reader |
| K061742 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
01/05/2009 |
| Jant Pharmacal Corporation Accustrip URS Reader |
| K061742 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
01/05/2009 |
| ReliOn micro Blood Glucose Monitoring System |
| K082417 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
01/05/2009 |
| SCI International Inc. New Choice Pro hCG Pregnancy Test Cassette Format |
| K050741 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
01/05/2009 |
| SCI International Inc. New Choice Pro Pregnancy Test Strip Format |
| K951705 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
01/05/2009 |
| Tyson Bioresearch, Inc., Diachex+ Evolve Blood Glucose Monitoring System |
| K073492 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
12/18/2008 |
| Fora Care Inc. FORA D15b Blood Glucose Plus Blood Pressure Monitoring System |
| K080014 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
12/17/2008 |
| Fora Care Inc. FORA D15z Blood Glucose Plus Blood Pressure Monitoring System |
| K080014 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
12/17/2008 |
| SCI International Inc. New Choice Pro hCG Pregnancy Test 2000 mIU/mL Cassette Format |
| K052694 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
12/17/2008 |
| Abbott ReliOn Ultima Advance Blood Glucose Monitoring System |
| K081975 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
12/08/2008 |
| Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood) |
| K950164 |
Calcium, Total |
General Chemistry |
12/04/2008 |
| Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood) |
| K942782 |
Albumin |
General Chemistry |
12/04/2008 |
| Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood) |
| K942782 |
Glucose |
General Chemistry |
12/04/2008 |
| Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood) |
| K942782 |
Creatinine |
General Chemistry |
12/04/2008 |
| Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood) |
| K942782 |
Urea (BUN) |
General Chemistry |
12/04/2008 |
| Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood) |
| K942782 |
Glucose |
General Chemistry |
12/04/2008 |
| Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood) |
| K942782 |
potassium |
General Chemistry |
12/04/2008 |
| Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood) |
| K942782 |
Creatinine |
General Chemistry |
12/04/2008 |
| Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood) |
| K942782 |
Urea (BUN) |
General Chemistry |
12/04/2008 |
| Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood) |
| K010670 |
chloride |
General Chemistry |
12/04/2008 |
| Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood) |
| K010670 |
chloride |
General Chemistry |
12/04/2008 |
| Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood) |
| K022312 |
Phosphorus |
General Chemistry |
12/04/2008 |
| Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood) |
| K992140 |
potassium |
General Chemistry |
12/04/2008 |
| Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood) |
| K992140 |
Carbon Dioxide, Total (CO2) |
General Chemistry |
12/04/2008 |
| Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood) |
| K992140 |
Creatine Kinase (CK) |
General Chemistry |
12/04/2008 |
| Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood) |
| K992140 |
Carbon Dioxide, Total (CO2) |
General Chemistry |
12/04/2008 |
| Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood) |
| K993211 |
Sodium |
General Chemistry |
12/04/2008 |
| Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood) |
| K993211 |
Sodium |
General Chemistry |
12/04/2008 |
| Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood) |
| K993211 |
Sodium |
General Chemistry |
12/04/2008 |
| Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood) |
| K993211 |
Sodium |
General Chemistry |
12/04/2008 |
| Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood) |
| K992140 |
Creatine Kinase (CK) |
General Chemistry |
12/04/2008 |
| Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood) |
| K992140 |
Carbon Dioxide, Total (CO2) |
General Chemistry |
12/04/2008 |
| Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood) |
| K992140 |
potassium |
General Chemistry |
12/04/2008 |
| Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood) |
| K992140 |
Carbon Dioxide, Total (CO2) |
General Chemistry |
12/04/2008 |
| Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood) |
| K022312 |
Phosphorus |
General Chemistry |
12/04/2008 |
| Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood) |
| K010670 |
chloride |
General Chemistry |
12/04/2008 |
| Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood) |
| K010670 |
chloride |
General Chemistry |
12/04/2008 |
| Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood) |
| K942782 |
Glucose |
General Chemistry |
12/04/2008 |
| Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood) |
| K942782 |
potassium |
General Chemistry |
12/04/2008 |
| Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood) |
| K942782 |
Creatinine |
General Chemistry |
12/04/2008 |
| Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood) |
| K942782 |
Urea (BUN) |
General Chemistry |
12/04/2008 |
| Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood) |
| K942782 |
Albumin |
General Chemistry |
12/04/2008 |
| Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood) |
| K942782 |
Glucose |
General Chemistry |
12/04/2008 |
| Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood) |
| K942782 |
Creatinine |
General Chemistry |
12/04/2008 |
| Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood) |
| K942782 |
Urea (BUN) |
General Chemistry |
12/04/2008 |
| Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood) |
| K950164 |
Calcium, Total |
General Chemistry |
12/04/2008 |
| Jant Pharmacal Accutest Dual Sample Immunological Fecal Occult Blood (iFOB) Test |
| K073431 |
Fecal Occult Blood |
General Chemistry |
12/04/2008 |
| Jant Pharmacal Accutest Immunological Fecal Occult Blood Test (iFOBT) |
| K063693 |
Fecal Occult Blood |
General Chemistry |
12/04/2008 |
| Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick Blood |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick pH |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick Protein |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick Ascorbic Acid |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 11SG Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 4 OB Urine Reagent Strips For Urinalysis |
| K061559 |
Urine Qualitative Dipstick Blood |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 4 OB Urine Reagent Strips For Urinalysis |
| K061559 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 4 OB Urine Reagent Strips For Urinalysis |
| K061559 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 4 OB Urine Reagent Strips For Urinalysis |
| K061559 |
Urine Qualitative Dipstick Protein |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 7 Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 7 Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick Blood |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 7 Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 7 Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 7 Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 7 Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick pH |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 7 Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick Protein |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick Blood |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick pH |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick Protein |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick Blood |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick pH |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick Protein |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
11/21/2008 |
| Diagnostic Test Group Clarity Urocheck Blood Urine Reagent Strips for Urinalysis |
| K061559 |
Urine Qualitative Dipstick Blood |
Urinalysis |
11/21/2008 |
| Abbott i-STAT 6+ Cartridge (Venous Whole blood) |
| K053110 |
Hemoglobin |
Hematology |
11/13/2008 |
| Abbott i-STAT 6+ Cartridge (Venous Whole blood) |
| K053110 |
Glucose |
General Chemistry |
11/13/2008 |
| Abbott i-STAT 6+ Cartridge (Venous Whole blood) |
| K053110 |
Sodium |
General Chemistry |
11/13/2008 |
| Abbott i-STAT 6+ Cartridge (Venous Whole blood) |
| K053110 |
potassium |
General Chemistry |
11/13/2008 |
| Abbott i-STAT 6+ Cartridge (Venous Whole blood) |
| K053110 |
Urea (BUN) |
General Chemistry |
11/13/2008 |
| Abbott i-STAT 6+ Cartridge (Venous Whole blood) |
| K053110 |
chloride |
General Chemistry |
11/13/2008 |
| Abbott i-STAT 6+ Cartridge (Venous Whole blood) |
| K053110 |
Hematocrit |
Hematology |
11/13/2008 |
| Abbott i-STAT Crea Cartridge (Venous Whole blood) |
| K053110 |
Creatinine |
General Chemistry |
11/13/2008 |
| Abbott i-STAT E3+ Cartridge (Venous Whole blood) |
| K053110 |
Hemoglobin |
Hematology |
11/13/2008 |
| Abbott i-STAT E3+ Cartridge (Venous Whole blood) |
| K053110 |
Sodium |
General Chemistry |
11/13/2008 |
| Abbott i-STAT E3+ Cartridge (Venous Whole blood) |
| K053110 |
potassium |
General Chemistry |
11/13/2008 |
| Abbott i-STAT E3+ Cartridge (Venous Whole blood) |
| K053110 |
Hematocrit |
Hematology |
11/13/2008 |
| Abbott i-STAT EC4+ Cartridge (Venous Whole blood) |
| K053110 |
Hemoglobin |
Hematology |
11/13/2008 |
| Abbott i-STAT EC4+ Cartridge (Venous Whole blood) |
| K053110 |
Glucose |
General Chemistry |
11/13/2008 |
| Abbott i-STAT EC4+ Cartridge (Venous Whole blood) |
| K053110 |
Sodium |
General Chemistry |
11/13/2008 |
| Abbott i-STAT EC4+ Cartridge (Venous Whole blood) |
| K053110 |
potassium |
General Chemistry |
11/13/2008 |
| Abbott i-STAT EC4+ Cartridge (Venous Whole blood) |
| K053110 |
Hematocrit |
Hematology |
11/13/2008 |
| Abbott i-STAT G Cartridge (Venous Whole blood) |
| K053110 |
Glucose |
General Chemistry |
11/13/2008 |
| Fora Care Inc. FORA D-10 Blood Glucose plus Blood Pressure Monitoring System |
| K081714 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
11/13/2008 |
| Nova Biomedical Nova Gold Blood Glucose Monitoring System |
| K070255 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
11/13/2008 |
| Siemens DCA 2000 analyzer |
| K951361 |
Glycated Hemoglobin, Total |
General Chemistry |
11/13/2008 |
| Siemens DCA 2000+ analyzer |
| K951361 |
Glycated Hemoglobin, Total |
General Chemistry |
11/13/2008 |
| Common Sense Ltd. Norma-Sense Vaginal Discharge pH Test |
| X070057 |
pH, Urine |
General Chemistry |
11/04/2008 |
| IM Diagnostics, Inc. IM Maxie 2 hCG Pregnancy Urine Cassette and Dipstick Tests |
| K070921 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
11/04/2008 |
| Mossman Associates, Inc. NicCheck I Test Strips |
| K963733 |
Nicotine And/Or Metabolites |
Toxicology / TDM |
11/04/2008 |
| Wako APOLOWAKO Analyzer {Whole Blood} |
| K080123 |
Glucose |
General Chemistry |
10/31/2008 |
| Wako APOLOWAKO Analyzer {Whole Blood} |
| K080123 |
Glycosylated Hemoglobin (Hgb A1c) |
General Chemistry |
10/31/2008 |
| Wako APOLOWAKO Analyzer (Whole Blood) |
| K080125 |
Triglyceride |
General Chemistry |
10/31/2008 |
| Wako APOLOWAKO Analyzer (Whole Blood) |
| K080125 |
Cholesterol |
General Chemistry |
10/31/2008 |
| IM Diagnostics, Inc. IM Confirms II plus hCG Pregnancy Serum/Urine Cassette and Dipstick Tests |
| K071030 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
10/28/2008 |
| Arkray USA, Inc. GLUCOCARD 01-mini Blood Glucose Monitoring System |
| K082417 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
10/23/2008 |
| i-SENS, Inc. CareSens II Blood Glucose Monitoring System |
| K080923 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
10/23/2008 |
| i-SENS, Inc. CareSens POP Blood Glucose Monitoring System |
| K080923 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
10/23/2008 |
| LifeScan OneTouch Vita Blood Glucose Monitoring System |
| K082513 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
10/23/2008 |
| Abbott Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System |
| K080960 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
10/17/2008 |
| Abbott Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System |
| K080960 |
Ketone, Blood |
General Chemistry |
10/17/2008 |
| Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine) |
| K061559 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
10/17/2008 |
| Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine) |
| K061559 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
10/17/2008 |
| Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine) |
| K061559 |
Urine Qualitative Dipstick Blood |
Urinalysis |
10/17/2008 |
| Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine) |
| K061559 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
10/17/2008 |
| Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine) |
| K061559 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
10/17/2008 |
| Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine) |
| K061559 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
10/17/2008 |
| Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine) |
| K061559 |
Urine Qualitative Dipstick pH |
Urinalysis |
10/17/2008 |
| Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine) |
| K061559 |
Urine Qualitative Dipstick Protein |
Urinalysis |
10/17/2008 |
| Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine) |
| K061559 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
10/17/2008 |
| Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine) |
| K061559 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
10/17/2008 |
| Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine) |
| K061559 |
Urine Qualitative Dipstick Ascorbic Acid |
Urinalysis |
10/17/2008 |
| Arkray USA, Inc. Assure 4 Blood Glucose Monitoring System |
| K070088 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
10/17/2008 |
| BTNX Rapid Response 10-SG Urinalysis Reagent Strip |
| K970250 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
10/17/2008 |
| BTNX Rapid Response 10-SG Urinalysis Reagent Strip |
| K970250 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
10/17/2008 |
| BTNX Rapid Response 10-SG Urinalysis Reagent Strip |
| K970250 |
Urine Qualitative Dipstick Blood |
Urinalysis |
10/17/2008 |
| BTNX Rapid Response 10-SG Urinalysis Reagent Strip |
| K970250 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
10/17/2008 |
| BTNX Rapid Response 10-SG Urinalysis Reagent Strip |
| K970250 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
10/17/2008 |
| BTNX Rapid Response 10-SG Urinalysis Reagent Strip |
| K970250 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
10/17/2008 |
| BTNX Rapid Response 10-SG Urinalysis Reagent Strip |
| K970250 |
Urine Qualitative Dipstick pH |
Urinalysis |
10/17/2008 |
| BTNX Rapid Response 10-SG Urinalysis Reagent Strip |
| K970250 |
Urine Qualitative Dipstick Protein |
Urinalysis |
10/17/2008 |
| BTNX Rapid Response 10-SG Urinalysis Reagent Strip |
| K970250 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
10/17/2008 |
| BTNX Rapid Response 10-SG Urinalysis Reagent Strip |
| K970250 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
10/17/2008 |
| Consult diagnostics Urine Analyzer |
| K050801 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
10/17/2008 |
| Consult diagnostics Urine Analyzer |
| K050801 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
10/17/2008 |
| Consult diagnostics Urine Analyzer |
| K050801 |
Urine Qualitative Dipstick Blood |
Urinalysis |
10/17/2008 |
| Consult diagnostics Urine Analyzer |
| K050801 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
10/17/2008 |
| Consult diagnostics Urine Analyzer |
| K050801 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
10/17/2008 |
| Consult diagnostics Urine Analyzer |
| K050801 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
10/17/2008 |
| Consult diagnostics Urine Analyzer |
| K050801 |
Urine Qualitative Dipstick pH |
Urinalysis |
10/17/2008 |
| Consult diagnostics Urine Analyzer |
| K050801 |
Urine Qualitative Dipstick Protein |
Urinalysis |
10/17/2008 |
| Consult diagnostics Urine Analyzer |
| K050801 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
10/17/2008 |
| Consult diagnostics Urine Analyzer |
| K050801 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
10/17/2008 |
| Vertex Diagnostics UltraTRAK PRO Blood Glucose Monitoring System |
| K082618 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
10/17/2008 |
| Bionime Corporation Rightest Blood Glucose Monitoring System, Model GM100 |
| K081451 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
09/25/2008 |
| QUIDEL QUICKVUE DIPSTICK STREP A (DIRECT THROAT SWAB) |
| K011097 |
Streptococcus, Group A |
Bacteriology |
09/25/2008 |
| Quidel QuickVue In-Line Strep A (direct from throat swab) |
| K934484 |
Streptococcus, Group A |
Bacteriology |
09/25/2008 |
| Quidel QuickVue Influenza A+B Test |
| K053146 |
Influenza A/B |
Virology |
09/25/2008 |
| Quidel QuickVue Influenza Test |
| K991633 |
Influenza A/B |
Virology |
09/25/2008 |
| Quidel QuickVue RSV Test |
| K061008 |
Respiratory Syncytial Virus |
Virology |
09/25/2008 |
| Quidel QuickVue RSV Test |
| K070747 |
Respiratory Syncytial Virus |
Virology |
09/25/2008 |
| Common Sense Ltd. VA-SENSE Kit |
| X070058 |
Vaginal pH |
General Chemistry |
09/18/2008 |
| EPS Bio Technology EasyPlus mini EasyMax self monitoring blood glucose system |
| K082121 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
09/18/2008 |
| Fora Comfort 2 in 1 TD-3250C Blood Glucose and Blood Pressure Monitoring System |
| K080014 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
09/18/2008 |
| Fora Comfort 2 in 1 TD-3260 Blood Glucose Plus Blood Pressure Monitoring System |
| K080014 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
09/18/2008 |
| Jant Pharmacal Accutest URS 10 Urine Reagent Strips |
| K052719 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
09/18/2008 |
| Jant Pharmacal Accutest URS 10 Urine Reagent Strips |
| K052719 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
09/18/2008 |
| Jant Pharmacal Accutest URS 10 Urine Reagent Strips |
| K052719 |
Urine Qualitative Dipstick Blood |
Urinalysis |
09/18/2008 |
| Jant Pharmacal Accutest URS 10 Urine Reagent Strips |
| K052719 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
09/18/2008 |
| Jant Pharmacal Accutest URS 10 Urine Reagent Strips |
| K052719 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
09/18/2008 |
| Jant Pharmacal Accutest URS 10 Urine Reagent Strips |
| K052719 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
09/18/2008 |
| Jant Pharmacal Accutest URS 10 Urine Reagent Strips |
| K052719 |
Urine Qualitative Dipstick pH |
Urinalysis |
09/18/2008 |
| Jant Pharmacal Accutest URS 10 Urine Reagent Strips |
| K052719 |
Urine Qualitative Dipstick Protein |
Urinalysis |
09/18/2008 |
| Jant Pharmacal Accutest URS 10 Urine Reagent Strips |
| K052719 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
09/18/2008 |
| Jant Pharmacal Accutest URS 10 Urine Reagent Strips |
| K052719 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
09/18/2008 |
| PSS World Medical QUINTET Blood Glucose Monitoring System |
| K072054 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
09/18/2008 |
| Taidoc Clever Chek TD-3250C Blood Glucose and Blood Pressure Monitoring System |
| K080014 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
09/18/2008 |
| Taidoc Clever Chek TD-3250D Blood Glucose and Blood Pressure Monitoring System |
| K080014 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
09/18/2008 |
| Bionime Corporation Rightest Blood Glucose Monitoring System, Model GM110 |
| K081450 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
09/12/2008 |
| Andon Health Co., Ltd., andon AG-605 Blood Glucose Monitoring System |
| K073030 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
09/04/2008 |
| Andon Health Co., Ltd., andon AG-606 Blood Glucose Monitoring System |
| K073030 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
09/04/2008 |
| Home Diagnostics TRUEresult Blood Glucose Monitoring System |
| K080641 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
08/20/2008 |
| Acon Laboratories Mission UTI Urinary Tract Infection Test Strips |
| K063295 |
Nitrite, Urine |
General Chemistry |
08/18/2008 |
| Acon Laboratories Mission UTI Urinary Tract Infection Test Strips |
| K063295 |
Leukocyte Esterase, Urinary |
Urinalysis |
08/18/2008 |
| American Bio Medica Rapid TOX |
| K053359 |
Amphetamines |
Toxicology / TDM |
08/18/2008 |
| American Bio Medica Rapid TOX |
| K053359 |
Cannabinoids (THC) |
Toxicology / TDM |
08/18/2008 |
| American Bio Medica Rapid TOX |
| K053359 |
Phencyclidine (PCP) |
Toxicology / TDM |
08/18/2008 |
| American Bio Medica Rapid TOX |
| K053359 |
Cocaine Metabolites |
Toxicology / TDM |
08/18/2008 |
| American Bio Medica Rapid TOX |
| K053359 |
Opiates |
Toxicology / TDM |
08/18/2008 |
| American Bio Medica Rapid TOX |
| K053359 |
Methadone |
Toxicology / TDM |
08/18/2008 |
| American Bio Medica Rapid TOX |
| K053359 |
Propoxyphene |
Toxicology / TDM |
08/18/2008 |
| American Bio Medica Rapid TOX |
| K053359 |
Methamphetamines |
Toxicology / TDM |
08/18/2008 |
| American Bio Medica Rapid TOX |
| K053359 |
Benzodiazepines |
Toxicology / TDM |
08/18/2008 |
| American Bio Medica Rapid TOX |
| K053359 |
Barbiturates |
Toxicology / TDM |
08/18/2008 |
| American Bio Medica Rapid TOX |
| K053359 |
Tricyclic Antidepressants |
Toxicology / TDM |
08/18/2008 |
| American Bio Medica Rapid TOX |
| K053359 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
08/18/2008 |
| American Bio Medica Rapid TOX |
| K053359 |
Oxycodone |
Toxicology / TDM |
08/18/2008 |
| American Bio Medica Rapid TOX |
| K053359 |
Buprenorphine |
Toxicology / TDM |
08/18/2008 |
| Home Diagnostics TRUE2go Blood Glucose Monitoring System |
| K080710 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
08/15/2008 |
| Inverness Medical Acceava hCG Urine II |
| K062361 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
08/14/2008 |
| Home Diagnostics, Home Care Delivered TrueTrack Smart System Blood Glucose Monitoring System |
| K032657 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
08/07/2008 |
| Home Diagnostics, Moore Medical TrueTrack Blood Glucose Monitoring System |
| K032657 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
08/07/2008 |
| Home Diagnostics, TrueTrack for Rite Aid Blood Glucose Monitoring System |
| K032657 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
08/07/2008 |
| Home Diagnostics, TrueTrack Live Better Blood Glucose Monitoring System |
| K032657 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
08/07/2008 |
| TaiDoc Technology Corporation U-Right TD-4247 Blood Glucose Monitoring System |
| K081957 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
08/07/2008 |
| Aventir Biotech LLC Home Check Multiple Drug Cup Test |
| K071489 |
Amphetamines |
Toxicology / TDM |
07/31/2008 |
| Aventir Biotech LLC Home Check Multiple Drug Cup Test |
| K071489 |
Phencyclidine (PCP) |
Toxicology / TDM |
07/31/2008 |
| Aventir Biotech LLC Home Check Multiple Drug Cup Test |
| K071489 |
Cocaine Metabolites |
Toxicology / TDM |
07/31/2008 |
| Aventir Biotech LLC Home Check Multiple Drug Cup Test |
| K071489 |
Methadone |
Toxicology / TDM |
07/31/2008 |
| Aventir Biotech LLC Home Check Multiple Drug Cup Test |
| K071489 |
Methamphetamines |
Toxicology / TDM |
07/31/2008 |
| Aventir Biotech LLC Home Check Multiple Drug Cup Test |
| K071489 |
Benzodiazepines |
Toxicology / TDM |
07/31/2008 |
| Aventir Biotech LLC Home Check Multiple Drug Cup Test |
| K071489 |
Barbiturates |
Toxicology / TDM |
07/31/2008 |
| Aventir Biotech LLC Home Check Multiple Drug Cup Test |
| K071489 |
Morphine |
Toxicology / TDM |
07/31/2008 |
| Aventir Biotech LLC Home Check Multiple Drug Cup Test |
| K071489 |
Tricyclic Antidepressants |
Toxicology / TDM |
07/31/2008 |
| Aventir Biotech LLC Home Check Multiple Drug Cup Test |
| K071489 |
Oxycodone |
Toxicology / TDM |
07/31/2008 |
| Avnetir Biotech LLC Home Check Multiple Drug Cup Test |
| K071489 |
Cannabinoids (THC) |
Toxicology / TDM |
07/31/2008 |
| Fora Care AudioChek Talking Mointors Blood Glucose Monitoring System Model TD-4237 |
| K081609 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
07/30/2008 |
| Fora Care Clever Chek TD-4237 Blood Glucose Monitoring System |
| K081609 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
07/30/2008 |
| Fora Care Inc. FORA TD-3224 Blood Glucose Plus Blood Pressure Monitoring System |
| K081714 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
07/30/2008 |
| Gluco Perfect LLC, Perfect Mini Blood Glucose Monitoring System |
| K052818 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
07/30/2008 |
| BTNX Inc. Rapid Response Immunological Fecal Occult Blood Test (IFOBT) |
| K061065 |
Fecal Occult Blood |
General Chemistry |
07/22/2008 |
| Healthcare Provider Direct OneStep Fecal Occult Blood (FOB) Screen Card Test |
| K063693 |
Fecal Occult Blood |
General Chemistry |
07/22/2008 |
| Roche Diagnostics ACCU-CHEK Compact Plus Blood Glucose Meter |
| K081389 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
07/22/2008 |
| Arkray USA, Inc. GLUCOCARD 01 Blood Glucose Monitoring System |
| K073416 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
07/17/2008 |
| Henry Schein One Step+ Strep A Dipstick Test |
| K010582 |
Streptococcus, Group A |
Bacteriology |
07/17/2008 |
| Germaine Laboratories Inc. AimStrip Urine Reagent Strips |
| K051727 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
07/14/2008 |
| Germaine Laboratories Inc. AimStrip Urine Reagent Strips |
| K051727 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
07/14/2008 |
| Germaine Laboratories Inc. AimStrip Urine Reagent Strips |
| K051727 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
07/14/2008 |
| Germaine Laboratories Inc. AimStrip Urine Reagent Strips |
| K051727 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
07/14/2008 |
| Germaine Laboratories, Inc. AimStrip Urine Reagent Strips |
| K051727 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
07/14/2008 |
| Germaine Laboratories, Inc. AimStrip Urine Reagent Strips |
| K051727 |
Urine Qualitative Dipstick Blood |
Urinalysis |
07/14/2008 |
| Germaine Laboratories, Inc. AimStrip Urine Reagent Strips |
| K051727 |
Urine Qualitative Dipstick Protein |
Urinalysis |
07/14/2008 |
| Germaine Laboratories, Inc. AimStrip Urine Reagent Strips |
| K051727 |
Urine Qualitative Dipstick pH |
Urinalysis |
07/14/2008 |
| Germaine Laboratories, Inc. AimStrip Urine Reagent Strips |
| K051727 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
07/14/2008 |
| Germaine Laboratories, Inc. AimStrip Urine Reagent Strips |
| K051727 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
07/14/2008 |
| Inverness Medical Acceava hCG Basic II |
| K993203 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
07/14/2008 |
| Inverness Medical Acceava hCG Combo II |
| K062361 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
07/14/2008 |
| BECKMAN COULTER HEMOCCULT ICT |
| K080812 |
Fecal Occult Blood |
General Chemistry |
07/01/2008 |
| Germaine Laboratories Compliance Gold iFOB (immunological fecal occult blood)Test |
| K063693 |
Fecal Occult Blood |
General Chemistry |
07/01/2008 |
| IDEAL LIFE Gluco-Manager GMM 0001 Blood Glucose Monitoring System |
| K080283 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/30/2008 |
| Tyson Bioresearch Inc. Diachex Basic Blood Glucose Monitoring System |
| K072854 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/30/2008 |
| Tyson Bioresearch Inc. Diachex Superb Blood Glucose Monitoring System |
| K072854 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/30/2008 |
| Tyson Bioresearch Inc. Diachex Vigor Blood Glucose Monitoring System |
| K072854 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/30/2008 |
| Germaine Laboratories AimStrip Pregnancy |
| K974368 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
06/26/2008 |
| AZO Test Strips Urinary Tract Infection Test |
| K063295 |
Nitrite, Urine |
General Chemistry |
06/25/2008 |
| AZO Test Strips Urinary Tract Infection Test |
| K063295 |
Leukocyte Esterase, Urinary |
Urinalysis |
06/25/2008 |
| Simple Diagnostics Clever Chek Auto-Code Voice Blood Glucose Monitoring System |
| K081144 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/23/2008 |
| HemoCue Albumin 201 System |
| K053253 |
Albumin, Urinary |
General Chemistry |
06/13/2008 |
| SpermCheck Vasectomy |
| K073039 |
Semen |
Hematology |
06/12/2008 |
| Henry Schein OneStepPlus Urine Analyzer |
| K061742 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
05/28/2008 |
| Henry Schein OneStepPlus Urine Analyzer |
| K061742 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
05/28/2008 |
| Henry Schein OneStepPlus Urine Analyzer |
| K061742 |
Urine Qualitative Dipstick Blood |
Urinalysis |
05/28/2008 |
| Henry Schein OneStepPlus Urine Analyzer |
| K061742 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
05/28/2008 |
| Henry Schein OneStepPlus Urine Analyzer |
| K061742 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
05/28/2008 |
| Henry Schein OneStepPlus Urine Analyzer |
| K061742 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
05/28/2008 |
| Henry Schein OneStepPlus Urine Analyzer |
| K061742 |
Urine Qualitative Dipstick pH |
Urinalysis |
05/28/2008 |
| Henry Schein OneStepPlus Urine Analyzer |
| K061742 |
Urine Qualitative Dipstick Protein |
Urinalysis |
05/28/2008 |
| Henry Schein OneStepPlus Urine Analyzer |
| K061742 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
05/28/2008 |
| Henry Schein OneStepPlus Urine Analyzer |
| K061742 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
05/28/2008 |
| Henry Schein OneStepPlus Urine Analyzer |
| K061742 |
Urine Qualitative Dipstick Ascorbic Acid |
Urinalysis |
05/28/2008 |
| Specialty Medical Supplies SureChek Edge Blood Glucose Monitoring System |
| K080501 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
05/28/2008 |
| Taidoc Technology ACHTUNG TD-4207 No Code Blood Glucose Monitoring System |
| K073494 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
05/28/2008 |
| Taidoc Technology CLEVER CHEK TD-4209 One-Code Blood Glucose Monitoring System |
| K073494 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
05/28/2008 |
| TaiDoc Technology CLEVER CHEK TD-4222 No Code Blood Glucose Monitoring System |
| K073494 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
05/28/2008 |
| Taidoc Technology CLEVER CHEK TD-4225 No Code Blood Glucose Monitoring System |
| K073494 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
05/28/2008 |
| Taidoc Technology CLEVER CHEK TD-4226 One-Code Blood Glucose Monitoring System |
| K073494 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
05/28/2008 |
| Diagnostic Test Group Clarity Ketone Urine Reagent Strips For Urinalysis |
| K061559 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
05/19/2008 |
| Diagnostic Test Group Clarity Urocheck 2 GP Urine Reagent Strips For Urinalysis |
| K061559 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
05/19/2008 |
| Diagnostic Test Group Clarity Urocheck 2 GP Urine Reagent Strips For Urinalysis |
| K061559 |
Urine Qualitative Dipstick Protein |
Urinalysis |
05/19/2008 |
| Diagnostic Test Group Clarity Urocheck 5 OB Urine Reagent Strips For Urinalysis |
| K061559 |
Urine Qualitative Dipstick Blood |
Urinalysis |
05/19/2008 |
| Diagnostic Test Group Clarity Urocheck 5 OB Urine Reagent Strips For Urinalysis |
| K061559 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
05/19/2008 |
| Diagnostic Test Group Clarity Urocheck 5 OB Urine Reagent Strips For Urinalysis |
| K061559 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
05/19/2008 |
| Diagnostic Test Group Clarity Urocheck 5 OB Urine Reagent Strips For Urinalysis |
| K061559 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
05/19/2008 |
| Diagnostic Test Group Clarity Urocheck 5 OB Urine Reagent Strips For Urinalysis |
| K061559 |
Urine Qualitative Dipstick Protein |
Urinalysis |
05/19/2008 |
| Home Diagnostics, Preferred Plus Pharmacy TRUEread Blood Glucose Monitoring System |
| K042080 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
04/29/2008 |
| AgaMatrix WaveSense KeyNote Pro Blood Glucose Monitoring System |
| K052762 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
04/24/2008 |
| AgaMatrix WaveSense Presto Blood Glucose Monitoring System |
| K073573 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
04/24/2008 |
| Target Corporation, EasyPRO Plus Blood Glucose Monitoring System |
| K063068 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
04/24/2008 |
| Apex Biotechnology Corp. GlucoSure Voice Blood Glucose Monitoring System |
| K073137 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
04/18/2008 |
| LifeScan One Touch UltraLink Blood Glucose Monitoring System |
| K073231 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
04/18/2008 |
| Neuero Engineering Inc. 3test Supreme Glucose Monitoring System |
| K072905 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
04/18/2008 |
| Abaxis Piccolo Blood Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood) |
| K023639 |
Triglyceride |
General Chemistry |
04/14/2008 |
| Abaxis Piccolo Blood Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood) |
| K023640 |
HDL Cholesterol |
General Chemistry |
04/14/2008 |
| Abaxis Piccolo Blood Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood) |
| K023642 |
Cholesterol |
General Chemistry |
04/14/2008 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood) |
| K023642 |
Cholesterol |
General Chemistry |
04/14/2008 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Reagent Disc} (Whole Blood) |
| K023642 |
Cholesterol |
General Chemistry |
04/14/2008 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood) |
| K023640 |
HDL Cholesterol |
General Chemistry |
04/14/2008 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Reagent Disc} (Whole Blood) |
| K023640 |
HDL Cholesterol |
General Chemistry |
04/14/2008 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood) |
| K023639 |
Triglyceride |
General Chemistry |
04/14/2008 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Reagent Disc} (Whole Blood) |
| K023639 |
Triglyceride |
General Chemistry |
04/14/2008 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood) |
| K942782 |
Glucose |
General Chemistry |
04/14/2008 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole Blood) |
| K942782 |
Albumin |
General Chemistry |
04/14/2008 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole Blood) |
| K942782 |
Protein, Total |
General Chemistry |
04/14/2008 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole Blood) |
| K942782 |
Aspartate Aminotransferase (AST) (SGOT) |
General Chemistry |
04/14/2008 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole Blood) |
| K942782 |
Bilirubin, Total |
General Chemistry |
04/14/2008 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Plus Reagenr Disc} (Whole Blood) |
| K942782 |
Aspartate Aminotransferase (AST) (SGOT) |
General Chemistry |
04/14/2008 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood) |
| K950164 |
Alanine Aminotransferase (ALT) (SGPT) |
General Chemistry |
04/14/2008 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole Blood) |
| K950164 |
Alanine Aminotransferase (ALT) (SGPT) |
General Chemistry |
04/14/2008 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole Blood) |
| K950164 |
Alkaline Phosphatase (ALP) |
General Chemistry |
04/14/2008 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole Blood) |
| K950164 |
Amylase |
General Chemistry |
04/14/2008 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole Blood) |
| K955770 |
Gamma Glutamyl Transferase (GGT) |
General Chemistry |
04/14/2008 |
| Apex Biotechnology Corp. GlucoSure Star Blood Glucose Monitoring System |
| K073648 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
04/14/2008 |
| Tyson Bioresearch Inc. Diachex+ Determine Blood Glucose Monitoring System |
| K073492 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
04/14/2008 |
| Tyson Bioresearch, Inc., Diachex+ Infinity Blood Glucose Monitoring System |
| K073492 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
04/14/2008 |
| Diagnostic Test Group Clarity Strep A Rapid Test Strips |
| K983386 |
Streptococcus, Group A |
Bacteriology |
04/08/2008 |
| Bayer A1CNow + (For professional use) |
| K051321 |
Glycated Hemoglobin, Total |
General Chemistry |
03/31/2008 |
| Fora Care Inc. Fora Comfort 2 in 1 Blood Glucose Plus Blood Pressure Monitoring System TD-3250 |
| K062800 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/26/2008 |
| HMD Biomedical Llc Evolution Blood Glucose Monitoring System |
| K072369 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/26/2008 |
| Inverness Medical Professional Diagnostics BioStar Acceava hCG Urine II |
| K062361 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
03/26/2008 |
| Tyson Bioresearch, Inc. EZ Scan Plus Blood Glucose Monitoring System |
| K072441 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/26/2008 |
| Inverness Medical BioStar Acceava Strep A Twist {Strep A} |
| K023766 |
Streptococcus, Group A |
Bacteriology |
03/19/2008 |
| Jant Pharmacal Accutest Integrated Strep A Rapid Test Device {Strep A} |
| K023766 |
Streptococcus, Group A |
Bacteriology |
03/19/2008 |
| Moore Medical The Supply Experts Strep A Test - Cassette {Strep A} |
| K023766 |
Streptococcus, Group A |
Bacteriology |
03/19/2008 |
| AmeriTek dBest One Step Occult Blood Test |
| K071242 |
Fecal Occult Blood |
General Chemistry |
03/12/2008 |
| Diagnostic Devices Prodigy Voice Blood Glucose Monitoring System |
| K073118 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/12/2008 |
| Diagnostic Test Group, Clarity Blood Glucose Monitoring System |
| K062829 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/12/2008 |
| Bestgen Major III Blood Glucose Monitoring System |
| K072274 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/04/2008 |
| Henry Schein One Step + Strep A Cassette Test |
| K023766 |
Streptococcus, Group A |
Bacteriology |
03/04/2008 |
| TaiDoc Clever Chek TD-4232 Blood Glucose Monitoring System |
| K073119 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/04/2008 |
| Qualigen, Inc. FastChek TSH (Whole Blood) |
| K990658 |
Thyroid Stimulating Hormone (TSH) |
Endocrinology |
02/29/2008 |
| Nova Biomedical Corp. StatStrip Glucose Hospital Meter |
| K060345 |
Glucose Monitoring Devices (Prescription Use Only) |
General Chemistry |
02/28/2008 |
| Nova Biomedical, Nova Max Link Blood Glucose Monitoring System |
| K040603 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
02/28/2008 |
| Henry Schein One Step + Mononucleosis Rapid Test Device (Whole Blood) |
| K042272 |
Infectious Mononucleosis Antibodies (Mono) |
General Immunology |
02/26/2008 |
| Quidel QuickVue RSV Test |
| K061008 |
Respiratory Syncytial Virus |
Virology |
02/25/2008 |
| Quidel QuickVue RSV Test |
| K070747 |
Respiratory Syncytial Virus |
Virology |
02/25/2008 |
| Clarity MONO Mononucleosis Rapid Test (Whole Blood) |
| K961024 |
Infectious Mononucleosis Antibodies (Mono) |
General Immunology |
02/13/2008 |
| AgaMatrix WaveSense KeyNote Codeless Blood Glucose Monitoring System |
| K073573 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
01/31/2008 |
| BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine) |
| K063545 |
Amphetamines |
Toxicology / TDM |
01/30/2008 |
| BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine) |
| K063545 |
Cannabinoids (THC) |
Toxicology / TDM |
01/30/2008 |
| BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine) |
| K063545 |
Phencyclidine (PCP) |
Toxicology / TDM |
01/30/2008 |
| BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine) |
| K063545 |
Cocaine Metabolites |
Toxicology / TDM |
01/30/2008 |
| BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine) |
| K063545 |
Methadone |
Toxicology / TDM |
01/30/2008 |
| BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine) |
| K063545 |
Methamphetamines |
Toxicology / TDM |
01/30/2008 |
| BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine) |
| K063545 |
Benzodiazepines |
Toxicology / TDM |
01/30/2008 |
| BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine) |
| K063545 |
Barbiturates |
Toxicology / TDM |
01/30/2008 |
| BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine) |
| K063545 |
Morphine |
Toxicology / TDM |
01/30/2008 |
| BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine) |
| K063545 |
Tricyclic Antidepressants |
Toxicology / TDM |
01/30/2008 |
| BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine) |
| K063545 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
01/30/2008 |
| BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine) |
| K063545 |
Amphetamines |
Toxicology / TDM |
01/30/2008 |
| BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine) |
| K063545 |
Cannabinoids (THC) |
Toxicology / TDM |
01/30/2008 |
| BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine) |
| K063545 |
Phencyclidine (PCP) |
Toxicology / TDM |
01/30/2008 |
| BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine) |
| K063545 |
Cocaine Metabolites |
Toxicology / TDM |
01/30/2008 |
| BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine) |
| K063545 |
Methadone |
Toxicology / TDM |
01/30/2008 |
| BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine) |
| K063545 |
Methamphetamines |
Toxicology / TDM |
01/30/2008 |
| BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine) |
| K063545 |
Benzodiazepines |
Toxicology / TDM |
01/30/2008 |
| BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine) |
| K063545 |
Barbiturates |
Toxicology / TDM |
01/30/2008 |
| BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine) |
| K063545 |
Morphine |
Toxicology / TDM |
01/30/2008 |
| BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine) |
| K063545 |
Tricyclic Antidepressants |
Toxicology / TDM |
01/30/2008 |
| BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine) |
| K063545 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
01/30/2008 |
| JANT Pharmacal Corporation Accutest Value + Urine Pregnancy Test Device |
| K993317 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
01/30/2008 |
| Phamatech At Home 12 Drug Test (Model 9308T) |
| K070009 |
Amphetamines |
Toxicology / TDM |
01/23/2008 |
| Phamatech At Home 12 Drug Test (Model 9308T) |
| K070009 |
Cannabinoids (THC) |
Toxicology / TDM |
01/23/2008 |
| Phamatech At Home 12 Drug Test (Model 9308T) |
| K070009 |
Phencyclidine (PCP) |
Toxicology / TDM |
01/23/2008 |
| Phamatech At Home 12 Drug Test (Model 9308T) |
| K070009 |
Cocaine Metabolites |
Toxicology / TDM |
01/23/2008 |
| Phamatech At Home 12 Drug Test (Model 9308T) |
| K070009 |
Benzodiazepines |
Toxicology / TDM |
01/23/2008 |
| Phamatech At Home 12 Drug Test (Model 9308T) |
| K070009 |
Barbiturates |
Toxicology / TDM |
01/23/2008 |
| Phamatech At Home 12 Drug Test (Model 9308T) |
| K070009 |
Opiates |
Toxicology / TDM |
01/23/2008 |
| Phamatech At Home 12 Drug Test (Model 9308T) |
| K070009 |
Methadone |
Toxicology / TDM |
01/23/2008 |
| Phamatech At Home 12 Drug Test (Model 9308T) |
| K070009 |
Methamphetamines |
Toxicology / TDM |
01/23/2008 |
| Phamatech At Home 12 Drug Test (Model 9308T) |
| K070009 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
01/23/2008 |
| Phamatech At Home 12 Drug Test (Model 9308Z) |
| K070009 |
Amphetamines |
Toxicology / TDM |
01/23/2008 |
| Phamatech At Home 12 Drug Test (Model 9308Z) |
| K070009 |
Cannabinoids (THC) |
Toxicology / TDM |
01/23/2008 |
| Phamatech At Home 12 Drug Test (Model 9308Z) |
| K070009 |
Phencyclidine (PCP) |
Toxicology / TDM |
01/23/2008 |
| Phamatech At Home 12 Drug Test (Model 9308Z) |
| K070009 |
Cocaine Metabolites |
Toxicology / TDM |
01/23/2008 |
| Phamatech At Home 12 Drug Test (Model 9308Z) |
| K070009 |
Opiates |
Toxicology / TDM |
01/23/2008 |
| Phamatech At Home 12 Drug Test (Model 9308Z) |
| K070009 |
Methadone |
Toxicology / TDM |
01/23/2008 |
| Phamatech At Home 12 Drug Test (Model 9308Z) |
| K070009 |
Methamphetamines |
Toxicology / TDM |
01/23/2008 |
| Phamatech At Home 12 Drug Test (Model 9308Z) |
| K070009 |
Benzodiazepines |
Toxicology / TDM |
01/23/2008 |
| Phamatech At Home 12 Drug Test (Model 9308Z) |
| K070009 |
Barbiturates |
Toxicology / TDM |
01/23/2008 |
| Phamatech At Home 12 Drug Test (Model 9308Z) |
| K070009 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
01/23/2008 |
| Phamatech At Home 12 Drug Test (Model 9308Z) |
| K070009 |
Oxycodone |
Toxicology / TDM |
01/23/2008 |
| Phamatech At Home 12 Drug Test (Model 930T) |
| K070009 |
Oxycodone |
Toxicology / TDM |
01/23/2008 |
| Becton Dickinson BD Chek Group A Strep Test |
| K010582 |
Streptococcus, Group A |
Bacteriology |
01/22/2008 |
| Diagnostic Test Group Clarity H. pylori Rapid Test Device (Whole Blood) |
| K980798 |
Helicobacter Pylori Antibodies |
General Immunology |
01/22/2008 |
| BTNX Inc. Rapid Response H. pylori Whole Blood Rapid Test Device |
| K024360 |
Helicobacter Pylori Antibodies |
General Immunology |
01/15/2008 |
| Abbott Diagnostics Signify ER Drug Screen Test |
| K041685 |
Amphetamines |
Toxicology / TDM |
01/08/2008 |
| Abbott Diagnostics Signify ER Drug Screen Test |
| K041685 |
Cannabinoids (THC) |
Toxicology / TDM |
01/08/2008 |
| Abbott Diagnostics Signify ER Drug Screen Test |
| K041685 |
Phencyclidine (PCP) |
Toxicology / TDM |
01/08/2008 |
| Abbott Diagnostics Signify ER Drug Screen Test |
| K041685 |
Cocaine Metabolites |
Toxicology / TDM |
01/08/2008 |
| Abbott Diagnostics Signify ER Drug Screen Test |
| K041685 |
Opiates |
Toxicology / TDM |
01/08/2008 |
| Abbott Diagnostics Signify ER Drug Screen Test |
| K041685 |
Propoxyphene |
Toxicology / TDM |
01/08/2008 |
| Abbott Diagnostics Signify ER Drug Screen Test |
| K041685 |
Benzodiazepines |
Toxicology / TDM |
01/08/2008 |
| Abbott Diagnostics Signify ER Drug Screen Test |
| K041685 |
Barbiturates |
Toxicology / TDM |
01/08/2008 |
| Abbott Diagnostics Signify ER Drug Screen Test |
| K041685 |
Tricyclic Antidepressants |
Toxicology / TDM |
01/08/2008 |
| Abbott Diagnostics Signify ER Drug Screen Test |
| K041685 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
01/08/2008 |
| Abbott Diagnostics Signify ER Drug Screen Test |
| K041685 |
Oxycodone |
Toxicology / TDM |
01/08/2008 |
| Accutech CholesTrak HDL Cholesterol Home Test |
| K072836 |
HDL Cholesterol |
General Chemistry |
01/08/2008 |
| Diagnostic Devices, Inc. Prodigy Autocode Blood Glucose Monitoring System |
| K072784 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
01/08/2008 |
| Jant Pharmacal Accutest Value + Mononucleosis Rapid Test (Whole Blood) |
| K042272 |
Infectious Mononucleosis Antibodies (Mono) |
General Immunology |
01/08/2008 |
| Stanbio Rely Mono Rapid Test (Whole Blood) |
| K042272 |
Infectious Mononucleosis Antibodies (Mono) |
General Immunology |
01/08/2008 |
| TaiDoc Technology Corporation Clever Chek TD-4227 Blood Glucose Monitoring System |
| K072784 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
01/08/2008 |
| Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test {midstream} (OTC) |
| K071930 |
hCG, Urine |
Endocrinology |
12/19/2007 |
| Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test {cassette} (OTC) |
| K071930 |
hCG, Urine |
Endocrinology |
12/19/2007 |
| Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test {strip} (OTC) |
| K071930 |
hCG, Urine |
Endocrinology |
12/19/2007 |
| Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test {cassette} (Professional Use) |
| K071930 |
hCG, Urine |
Endocrinology |
12/19/2007 |
| Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test {midstream} (professional) |
| K071930 |
hCG, Urine |
Endocrinology |
12/19/2007 |
| Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test {strip} (professional) |
| K071930 |
hCG, Urine |
Endocrinology |
12/19/2007 |
| Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup (Professional Use) |
| K050878 |
Amphetamines |
Toxicology / TDM |
12/13/2007 |
| Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup (Professional Use) |
| K050878 |
Cannabinoids (THC) |
Toxicology / TDM |
12/13/2007 |
| Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup (Professional Use) |
| K050878 |
Phencyclidine (PCP) |
Toxicology / TDM |
12/13/2007 |
| Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup (Professional Use) |
| K050878 |
Cocaine Metabolites |
Toxicology / TDM |
12/13/2007 |
| Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup (Professional Use) |
| K050878 |
Opiates |
Toxicology / TDM |
12/13/2007 |
| Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup (Professional Use) |
| K050878 |
Methamphetamines |
Toxicology / TDM |
12/13/2007 |
| Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup (Professional Use) |
| K050878 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
12/13/2007 |
| EPS Bio Technology EasyPlus mini Self Monitoring Blood Glucose System |
| K070053 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
12/06/2007 |
| Gluco Perfect L.L.C., Gluco Perfect 2 Blood Glucose Monitoring System |
| K062799 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
12/06/2007 |
| Jant Pharmacal Accutest Value + H. pylori Rapid Test Device (Whole Blood) |
| K024350 |
Helicobacter Pylori Antibodies |
General Immunology |
11/26/2007 |
| Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis |
| K052719 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
11/16/2007 |
| Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis |
| K052719 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
11/16/2007 |
| Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis |
| K052719 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
11/16/2007 |
| Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis |
| K052719 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
11/16/2007 |
| Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis |
| K052719 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
11/16/2007 |
| Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis |
| K052719 |
Urine Qualitative Dipstick Blood |
Urinalysis |
11/16/2007 |
| Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis |
| K052719 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
11/16/2007 |
| Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis |
| K052719 |
Urine Qualitative Dipstick pH |
Urinalysis |
11/16/2007 |
| Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis |
| K052719 |
Urine Qualitative Dipstick Protein |
Urinalysis |
11/16/2007 |
| Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis |
| K052719 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
11/16/2007 |
| JANT Pharmacal Corporation Accutest Value + Urine/Serum Pregnancy Test Device |
| K993065 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
11/16/2007 |
| Vertex Diagnostics UltraTRAK Blood Glucose Monitoring System |
| K062235 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
11/16/2007 |
| Macherey-Nagel URYXXON Relax |
| K061742 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
11/08/2007 |
| Macherey-Nagel URYXXON Relax |
| K061742 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
11/08/2007 |
| Macherey-Nagel URYXXON Relax |
| K061742 |
Urine Qualitative Dipstick Blood |
Urinalysis |
11/08/2007 |
| Macherey-Nagel URYXXON Relax |
| K061742 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
11/08/2007 |
| Macherey-Nagel URYXXON Relax |
| K061742 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
11/08/2007 |
| Macherey-Nagel URYXXON Relax |
| K061742 |
Urine Qualitative Dipstick pH |
Urinalysis |
11/08/2007 |
| Macherey-Nagel URYXXON Relax |
| K061742 |
Urine Qualitative Dipstick Protein |
Urinalysis |
11/08/2007 |
| Macherey-Nagel URYXXON Relax |
| K061742 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
11/08/2007 |
| Macherey-Nagel URYXXON Relax |
| K061742 |
Urine Qualitative Dipstick Ascorbic Acid |
Urinalysis |
11/08/2007 |
| Macherey-Nagel URYXXON Relax |
| K061742 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
11/08/2007 |
| Macherey-Nagel URYXXON Relax |
| K061742 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
11/08/2007 |
| BinaxNOW Influenza A & B Test (Nasopharyngeal (Np) Swab And Nasal Wash/Aspirate Specimens and Nasal Swabs (NS)) |
| K062109 |
Influenza A/B |
Virology |
11/01/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood) |
| K010670 |
chloride |
General Chemistry |
10/30/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood) |
| K010670 |
chloride |
General Chemistry |
10/30/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {Electrolyte Metabolic Reagent Disc} (Whole Blood) |
| K010670 |
chloride |
General Chemistry |
10/30/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood) |
| K993211 |
Albumin |
General Chemistry |
10/30/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood) |
| K993211 |
Protein, Total |
General Chemistry |
10/30/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood) |
| K993211 |
Alanine Aminotransferase (ALT) (SGPT) |
General Chemistry |
10/30/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood) |
| K993211 |
Calcium, Total |
General Chemistry |
10/30/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood) |
| K993211 |
Aspartate Aminotransferase (AST) (SGOT) |
General Chemistry |
10/30/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood) |
| K993211 |
Glucose |
General Chemistry |
10/30/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood) |
| K993211 |
Sodium |
General Chemistry |
10/30/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood) |
| K993211 |
Creatinine |
General Chemistry |
10/30/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood) |
| K993211 |
Alkaline Phosphatase (ALP) |
General Chemistry |
10/30/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood) |
| K993211 |
Urea (BUN) |
General Chemistry |
10/30/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood) |
| K993211 |
Bilirubin, Total |
General Chemistry |
10/30/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood) |
| K993211 |
Calcium, Total |
General Chemistry |
10/30/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood) |
| K993211 |
Glucose |
General Chemistry |
10/30/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood) |
| K993211 |
Sodium |
General Chemistry |
10/30/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood) |
| K993211 |
Creatinine |
General Chemistry |
10/30/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood) |
| K993211 |
Urea (BUN) |
General Chemistry |
10/30/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {Electrolyte Metabolic Reagent Disc} (Whole Blood) |
| K993211 |
Sodium |
General Chemistry |
10/30/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood) |
| K992140 |
potassium |
General Chemistry |
10/30/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood) |
| K992140 |
Carbon Dioxide, Total (CO2) |
General Chemistry |
10/30/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood) |
| K992140 |
potassium |
General Chemistry |
10/30/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood) |
| K992140 |
Carbon Dioxide, Total (CO2) |
General Chemistry |
10/30/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {Electrolyte Reagent Disc} (Whole Blood) |
| K992140 |
potassium |
General Chemistry |
10/30/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {Electrolyte Reagent Disc} (Whole Blood) |
| K992140 |
Carbon Dioxide, Total (CO2) |
General Chemistry |
10/30/2007 |
| Abaxis Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood) |
| K993211 |
Protein, Total |
General Chemistry |
10/30/2007 |
| Abaxis Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood) |
| K993211 |
Calcium, Total |
General Chemistry |
10/30/2007 |
| Abaxis Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood) |
| K993211 |
Creatinine |
General Chemistry |
10/30/2007 |
| Abaxis Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood) |
| K993211 |
Urea (BUN) |
General Chemistry |
10/30/2007 |
| Abaxis Piccolo xpress Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood) |
| K993211 |
Calcium, Total |
General Chemistry |
10/30/2007 |
| Abaxis Piccolo xpress Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood) |
| K993211 |
Creatinine |
General Chemistry |
10/30/2007 |
| Abaxis Piccolo xpress Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood) |
| K993211 |
Urea (BUN) |
General Chemistry |
10/30/2007 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood) |
| K993211 |
Albumin |
General Chemistry |
10/30/2007 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood) |
| K993211 |
Alanine Aminotransferase (ALT) (SGPT) |
General Chemistry |
10/30/2007 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood) |
| K993211 |
Aspartate Aminotransferase (AST) (SGOT) |
General Chemistry |
10/30/2007 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood) |
| K993211 |
Glucose |
General Chemistry |
10/30/2007 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood) |
| K993211 |
Sodium |
General Chemistry |
10/30/2007 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood) |
| K993211 |
Alkaline Phosphatase (ALP) |
General Chemistry |
10/30/2007 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood) |
| K993211 |
Bilirubin, Total |
General Chemistry |
10/30/2007 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood) |
| K993211 |
Glucose |
General Chemistry |
10/30/2007 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood) |
| K993211 |
Sodium |
General Chemistry |
10/30/2007 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Electrolyte Metabolic Reagent Disc} (Whole Blood) |
| K993211 |
Sodium |
General Chemistry |
10/30/2007 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood) |
| K992140 |
Carbon Dioxide, Total (CO2) |
General Chemistry |
10/30/2007 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc,} (Whole Blood) |
| K992140 |
potassium |
General Chemistry |
10/30/2007 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood) |
| K992140 |
Carbon Dioxide, Total (CO2) |
General Chemistry |
10/30/2007 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Electrolyte Reagent Disc} (Whole Blood) |
| K992140 |
potassium |
General Chemistry |
10/30/2007 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Electrolyte Reagent Disc} (Whole Blood) |
| K992140 |
Carbon Dioxide, Total (CO2) |
General Chemistry |
10/30/2007 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Basic Metabolic Reagent Disc,} (Whole Blood) |
| K992140 |
potassium |
General Chemistry |
10/30/2007 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood) |
| K010670 |
chloride |
General Chemistry |
10/30/2007 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood) |
| K010670 |
chloride |
General Chemistry |
10/30/2007 |
| Abaxis, Piccolo xpress Chemistry Analyzer {Electrolyte Metabolic Reagent Disc} (Whole Blood) |
| K010670 |
chloride |
General Chemistry |
10/30/2007 |
| Gluco Perfect, L.L.C. Gluco Perfect Blood Glucose Monitoring System |
| K032029 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
10/30/2007 |
| QuantRx Biomedical QuantRx Female Fertility Test |
| K070484 |
Follicle Stimulating Hormone (FSH) |
Endocrinology |
10/29/2007 |
| PSS World Medical Select Diagnostics hCG Dipstick |
| K993203 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
10/25/2007 |
| Heritage House '76 Inc., The Precious Feet Premium Pregnancy Test |
| K050741 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
10/24/2007 |
| Abbott Diabetes Care Inc. Precision Xceed Pro Glucose Monitoring System |
| K022941 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
10/22/2007 |
| Clearview COMPLETE HIV 1/2 (Fingerstick Veinipuncture, whole blood, ) |
| BP050009 |
HIV-1 and HIV-2 Antibodies |
General Immunology |
10/22/2007 |
| Abaxis Piccolo xpress Chemistry Analyzer {Kidney Check Panel} (Whole Blood) |
| K942782 |
Creatinine |
General Chemistry |
10/18/2007 |
| Abaxis Piccolo xpress Chemistry Analyzer {Kidney Check Panel} (Whole Blood) |
| K942782 |
Urea (BUN) |
General Chemistry |
10/18/2007 |
| ACON Laboratories UTI Urinary Tract Infection Test Strips |
| K063295 |
Nitrite, Urine |
General Chemistry |
10/15/2007 |
| ACON Laboratories UTI Urinary Tract Infection Test Strips |
| K063295 |
Leukocyte Esterase, Urinary |
Urinalysis |
10/15/2007 |
| Duramed Pharmaceuticals, Inc. AmniScreen Home Detection Liner Kit |
| K071100 |
Vaginal pH |
General Chemistry |
10/15/2007 |
| Polymer Technology Systems Cardiochek Brand Analyzer {PTS PANELS CHOL+HDL Panel Test Strips} |
| K071593 |
Cholesterol |
General Chemistry |
10/15/2007 |
| Polymer Technology Systems Cardiochek Brand Analyzer {PTS PANELS CHOL+HDL Panel Test Strips} |
| K071593 |
HDL Cholesterol |
General Chemistry |
10/15/2007 |
| Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS CHOL+HDL Panel Test Strips} |
| K071593 |
HDL Cholesterol |
General Chemistry |
10/15/2007 |
| Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS CHOL+HDL Panel Test Strips} |
| K071593 |
Cholesterol |
General Chemistry |
10/15/2007 |
| Tyson Bioresearch, Inc. Ultimate EZ Smart Plus Blood Glucose Monitoring System |
| K052818 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
10/15/2007 |
| Lifescan, Inc. OneTouch Select Meter |
| K072543 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
10/11/2007 |
| Siemens Medical Diagnostics DCA Vantage Analyzer |
| K071466 |
Glycosylated Hemoglobin (Hgb A1c) |
General Chemistry |
10/11/2007 |
| BTNX Inc. Clarity Fecal Occult Blood (FOB) Self Test |
| K070660 |
Fecal Occult Blood |
General Chemistry |
10/05/2007 |
| BTNX Inc. Know Fecal Occult Blood (FOB) Self Test |
| K070660 |
Fecal Occult Blood |
General Chemistry |
10/05/2007 |
| BTNX Inc. Rapid Response Fecal Occult Blood (FOB) Self Test |
| K070660 |
Fecal Occult Blood |
General Chemistry |
10/05/2007 |
| TaiDoc Advocate Redi-Code Blood Glucose Monitoring System |
| K072039 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
10/04/2007 |
| AgaMatrix WaveSense Jazz Blood Glucose Monitoring System |
| K072413 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
10/02/2007 |
| Abbott i-STAT CHEM8+ Catridge (Venous Whole blood) |
| K053110 |
Hemoglobin |
Hematology |
09/21/2007 |
| Abbott i-STAT CHEM8+ Catridge (Venous Whole blood) |
| K053110 |
Glucose |
General Chemistry |
09/21/2007 |
| Abbott i-STAT CHEM8+ Catridge (Venous Whole blood) |
| K053110 |
Sodium |
General Chemistry |
09/21/2007 |
| Abbott i-STAT CHEM8+ Catridge (Venous Whole blood) |
| K053110 |
potassium |
General Chemistry |
09/21/2007 |
| Abbott i-STAT CHEM8+ Catridge (Venous Whole blood) |
| K053110 |
Calcium, Ionized |
General Chemistry |
09/21/2007 |
| Abbott i-STAT CHEM8+ Catridge (Venous Whole blood) |
| K053110 |
Creatinine |
General Chemistry |
09/21/2007 |
| Abbott i-STAT CHEM8+ Catridge (Venous Whole blood) |
| K053110 |
Urea (BUN) |
General Chemistry |
09/21/2007 |
| Abbott i-STAT CHEM8+ Catridge (Venous Whole blood) |
| K053110 |
chloride |
General Chemistry |
09/21/2007 |
| Abbott i-STAT CHEM8+ Catridge (Venous Whole blood) |
| K053110 |
Carbon Dioxide, Total (CO2) |
General Chemistry |
09/21/2007 |
| Abbott i-STAT CHEM8+ Catridge (Venous Whole blood) |
| K053110 |
Hematocrit |
Hematology |
09/21/2007 |
| Abbott Laboratories Signify hCG Urine Dipstick |
| K993203 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
09/21/2007 |
| Moore Medical The Supply Experts hCG Urine -Dipstick |
| K993203 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
09/21/2007 |
| Moore Medical The Supply Experts hCG Urine-Cassette |
| K993317 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
09/21/2007 |
| Polymer Technology Systems Cardiochek Brand Analyzer {PTS PANELS CHOL+HDL+GLUC Panel Test Strips} |
| K071507 |
HDL Cholesterol |
General Chemistry |
09/21/2007 |
| Polymer Technology Systems Cardiochek Brand Analyzer {PTS PANELS CHOL+HDL+GLUC Panel Test Strips} |
| K071507 |
Glucose |
General Chemistry |
09/21/2007 |
| Polymer Technology Systems Cardiochek Brand Analyzer {PTS PANELS CHOL+HDL+GLUC Panel Test Strips} |
| K071507 |
Cholesterol |
General Chemistry |
09/21/2007 |
| Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS CHOL+HDL+GLUC Panel Test Strips} |
| K071507 |
Glucose |
General Chemistry |
09/21/2007 |
| Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS CHOL+HDL+GLUC Panel Test Strips} |
| K071507 |
Cholesterol |
General Chemistry |
09/21/2007 |
| Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS CHOL+HDL+GLUC Panel Test Strips} |
| K071507 |
HDL Cholesterol |
General Chemistry |
09/21/2007 |
| TaiDoc REVOLUTION TD-4229 Blood Glucose Monitoring System |
| K072489 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
09/21/2007 |
| US Diagnostics, Inc. Maxima Blood Glucose Monitoring System |
| K051651 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
09/20/2007 |
| Polymedco Poly Stat Strep A Dipstick |
| K010582 |
Streptococcus, Group A |
Bacteriology |
09/18/2007 |
| Abbott Laboratories Signify H. pylori Cassette (Whole Blood) |
| K024350 |
Helicobacter Pylori Antibodies |
General Immunology |
09/11/2007 |
| AI DE Diagnostic Co. One Step HCG Serum/Urine Combo Pregnancy Test (Cassette Style) |
| K062703 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
09/11/2007 |
| AI DE Diagnostic Co. One Step HCG Serum/Urine Combo Pregnancy Test (Strip Style) |
| K062703 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
09/11/2007 |
| AI DE Diagnostic Co. One Step HCG Urine Pregnancy Test (Cassette Style) |
| K062703 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
09/11/2007 |
| AI DE Diagnostic Co. One Step HCG Urine Pregnancy Test (Midstream) |
| K062703 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
09/11/2007 |
| AI DE Diagnostic Co. One Step HCG Urine Pregnancy Test (Strip Style) |
| K062703 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
09/11/2007 |
| Inverness Medical Professional Diagnostics Clearview 25 hCG Combo |
| K993065 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
08/24/2007 |
| Inverness Medical Professional Diagnostics Signify hCG Combo Cassette |
| K993065 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
08/24/2007 |
| Moore Medical The Supply Experts hCG Serum/Urine Test-Cassette |
| K993065 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
08/24/2007 |
| Polymedco, Inc. Poly stat hCG Test (Urine/Serum) |
| K993065 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
08/24/2007 |
| Abbott Laboratories Signify Strep A Dipstick |
| K010582 |
Streptococcus, Group A |
Bacteriology |
08/21/2007 |
| Jant Pharmacal Accustrip Strep A Value+ Test Strip |
| K010582 |
Streptococcus, Group A |
Bacteriology |
08/21/2007 |
| JANT Pharmacal Corp. Accustrip Value+ hCG One Step Pregnancy Test Strip (Urine) |
| K993203 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
08/17/2007 |
| Henry Schein, Inc. One Step + hCG Combo Test |
| K993065 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
08/16/2007 |
| Henry Schein, Inc. One Step + hCG Urine Cassette Test |
| K993317 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
08/16/2007 |
| Henry Schein, Inc. One Step + hCG Urine Strip Test |
| K993203 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
08/16/2007 |
| Lightstar Enterprises, Inc. GlucoTest Excel Blood Glucose Monitoring System |
| K043512 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
08/16/2007 |
| Moore Medical The Supply Experts Strep A Rapid Test - Dipstick |
| K010582 |
Streptococcus, Group A |
Bacteriology |
08/14/2007 |
| Arkray GLUCOCARD X-METER Blood Glucose Monitoring System |
| K063771 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
08/09/2007 |
| Physicians Medical Supply Quick Chek ultra Blood Glucose Monitoring System |
| K062235 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
08/09/2007 |
| Jant Pharmacal Accutest SplitCup (Professional Use) |
| K050878 |
Amphetamines |
Toxicology / TDM |
08/07/2007 |
| Jant Pharmacal Accutest SplitCup (Professional Use) |
| K050878 |
Cannabinoids (THC) |
Toxicology / TDM |
08/07/2007 |
| Jant Pharmacal Accutest SplitCup (Professional Use) |
| K050878 |
Phencyclidine (PCP) |
Toxicology / TDM |
08/07/2007 |
| Jant Pharmacal Accutest SplitCup (Professional Use) |
| K050878 |
Cocaine Metabolites |
Toxicology / TDM |
08/07/2007 |
| Jant Pharmacal Accutest SplitCup (Professional Use) |
| K050878 |
Opiates |
Toxicology / TDM |
08/07/2007 |
| Jant Pharmacal Accutest SplitCup (Professional Use) |
| K050878 |
Methamphetamines |
Toxicology / TDM |
08/07/2007 |
| Jant Pharmacal Accutest SplitCup (Professional Use) |
| K050878 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
08/07/2007 |
| AgaMatrix Jazz Blood Glucose Monitoring System |
| K071393 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
07/27/2007 |
| Exir Pharmaceutical Maximed Exichek TD-4224 Blood Glucose Monitoring System |
| K070239 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
07/27/2007 |
| Henry Schein One Step + H. Pylori Rapid Test Device {Whole Blood} (H. Pylori) |
| K024350 |
Helicobacter Pylori Antibodies |
General Immunology |
07/25/2007 |
| Polymedco Poly Stat H. Pylori Test {Whole Blood} (H. Pylori) |
| K024350 |
Helicobacter Pylori Antibodies |
General Immunology |
07/25/2007 |
| Cardinal Health SP Brand Rapid Test hCG Combo |
| K062361 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
07/12/2007 |
| Clearview MONO Whole Blood (Whole Blood) |
| K042272 |
Infectious Mononucleosis Antibodies (Mono) |
General Immunology |
07/12/2007 |
| HENRY SCHEIN ONE STEP+ MONO TEST (Whole Blood) |
| K042272 |
Infectious Mononucleosis Antibodies (Mono) |
General Immunology |
07/12/2007 |
| Inverness Medical Clearview hCG Combo II |
| K062361 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
07/12/2007 |
| Poly Stat Mono Test (Whole Blood) |
| K042272 |
Infectious Mononucleosis Antibodies (Mono) |
General Immunology |
07/12/2007 |
| PSS World Medical Select Diagnostics hCG Combo Cassette |
| K062361 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
07/12/2007 |
| PSS World Medical Select Diagnostics hCG Urine Cassette |
| K062361 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
07/12/2007 |
| Signify Mono Cassette (Whole Blood) |
| K042272 |
Infectious Mononucleosis Antibodies (Mono) |
General Immunology |
07/12/2007 |
| Home Diagnostics, facil TRUEread Blood Glucose Monitoring System |
| K042080 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
07/03/2007 |
| Home Diagnostics, Good Neighbor Pharmacy TRUEread Blood Glucose Monitoring System |
| K042080 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
07/03/2007 |
| Home Diagnostics, Invacare TRUEread Blood Glucose Monitoring System |
| K042080 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
07/03/2007 |
| Home Diagnostics, Leader TRUEread Blood Glucose Monitoring System |
| K042080 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
07/03/2007 |
| Home Diagnostics, sunmark TRUEread Blood Glucose Monitoring System |
| K042080 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
07/03/2007 |
| Applied DNA Technologies Bionexia hCG Pregnancy Cassette and Dipstick Tests |
| K070921 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
07/02/2007 |
| Bionexia hCG Pregnancy Serum/Urine Cassette and Dipstick Tests |
| K071030 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
07/02/2007 |
| Select Diagnostics Rapid Test Mono Cassette (Whole Blood) |
| K042272 |
Infectious Mononucleosis Antibodies (Mono) |
General Immunology |
07/02/2007 |
| Visgeneer, Inc. eBsensor Blood Glucose Monitoring System |
| K062555 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
07/02/2007 |
| Alfa Scientific Designs Fecal Occult Blood (FOB) Self-Test |
| K070660 |
Fecal Occult Blood |
General Chemistry |
06/28/2007 |
| Alfa Scientific Designs Instant-View Fecal Occult Blood (FOB) Self-Test (cassette) |
| K070660 |
Fecal Occult Blood |
General Chemistry |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant Verdict Multi-Drug of Abuse Urine Test |
| K063545 |
Amphetamines |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant Verdict Multi-Drug of Abuse Urine Test |
| K063545 |
Cannabinoids (THC) |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant Verdict Multi-Drug of Abuse Urine Test |
| K063545 |
Phencyclidine (PCP) |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant Verdict Multi-Drug of Abuse Urine Test |
| K063545 |
Cocaine Metabolites |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant Verdict Multi-Drug of Abuse Urine Test |
| K063545 |
Methadone |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant Verdict Multi-Drug of Abuse Urine Test |
| K063545 |
Methamphetamines |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant Verdict Multi-Drug of Abuse Urine Test |
| K063545 |
Benzodiazepines |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant Verdict Multi-Drug of Abuse Urine Test |
| K063545 |
Barbiturates |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant Verdict Multi-Drug of Abuse Urine Test |
| K063545 |
Morphine |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant Verdict Multi-Drug of Abuse Urine Test |
| K063545 |
Tricyclic Antidepressants |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant Verdict Multi-Drug of Abuse Urine Test |
| K063545 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Test |
| K063545 |
Amphetamines |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Test |
| K063545 |
Cannabinoids (THC) |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Test |
| K063545 |
Phencyclidine (PCP) |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Test |
| K063545 |
Cocaine Metabolites |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Test |
| K063545 |
Methadone |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Test |
| K063545 |
Methamphetamines |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Test |
| K063545 |
Benzodiazepines |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Test |
| K063545 |
Barbiturates |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Test |
| K063545 |
Morphine |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Test |
| K063545 |
Tricyclic Antidepressants |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Test |
| K063545 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant-Verdict Multi-Drug of Abuse Urine Cup Test |
| K063545 |
Amphetamines |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant-Verdict Multi-Drug of Abuse Urine Cup Test |
| K063545 |
Cannabinoids (THC) |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant-Verdict Multi-Drug of Abuse Urine Cup Test |
| K063545 |
Phencyclidine (PCP) |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant-Verdict Multi-Drug of Abuse Urine Cup Test |
| K063545 |
Cocaine Metabolites |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant-Verdict Multi-Drug of Abuse Urine Cup Test |
| K063545 |
Methadone |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant-Verdict Multi-Drug of Abuse Urine Cup Test |
| K063545 |
Benzodiazepines |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant-Verdict Multi-Drug of Abuse Urine Cup Test |
| K063545 |
Barbiturates |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant-Verdict Multi-Drug of Abuse Urine Cup Test |
| K063545 |
Morphine |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant-Verdict Multi-Drug of Abuse Urine Cup Test |
| K063545 |
Tricyclic Antidepressants |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant-Verdict Multi-Drug of Abuse Urine Cup Test |
| K063545 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Cup Test |
| K063545 |
Amphetamines |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Cup Test |
| K063545 |
Cannabinoids (THC) |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Cup Test |
| K063545 |
Phencyclidine (PCP) |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Cup Test |
| K063545 |
Cocaine Metabolites |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Cup Test |
| K063545 |
Methadone |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Cup Test |
| K063545 |
Benzodiazepines |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Cup Test |
| K063545 |
Barbiturates |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Cup Test |
| K063545 |
Morphine |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Cup Test |
| K063545 |
Tricyclic Antidepressants |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Cup Test |
| K063545 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Cup Test |
| K063545 |
Amphetamines |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Cup Test |
| K063545 |
Cannabinoids (THC) |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Cup Test |
| K063545 |
Phencyclidine (PCP) |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Cup Test |
| K063545 |
Cocaine Metabolites |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Cup Test |
| K063545 |
Methadone |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Cup Test |
| K063545 |
Methamphetamines |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Cup Test |
| K063545 |
Benzodiazepines |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Cup Test |
| K063545 |
Barbiturates |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Cup Test |
| K063545 |
Morphine |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Cup Test |
| K063545 |
Tricyclic Antidepressants |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Cup Test |
| K063545 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Test |
| K063545 |
Amphetamines |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Test |
| K063545 |
Cannabinoids (THC) |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Test |
| K063545 |
Phencyclidine (PCP) |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Test |
| K063545 |
Cocaine Metabolites |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Test |
| K063545 |
Methadone |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Test |
| K063545 |
Methamphetamines |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Test |
| K063545 |
Benzodiazepines |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Test |
| K063545 |
Barbiturates |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Test |
| K063545 |
Morphine |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Test |
| K063545 |
Tricyclic Antidepressants |
Toxicology / TDM |
06/28/2007 |
| Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Test |
| K063545 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
06/28/2007 |
| Arkray, PocketChem EZ Blood Glucose Monitoring System |
| K063068 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/28/2007 |
| Cardinal Health SP Brand Rapid Test hCG Cassette |
| K993317 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
06/28/2007 |
| Cardinal Health SP Brand Rapid Test hCG Combo Cassette |
| K062361 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
06/28/2007 |
| Cardinal Health SP Brand Rapid Test hCG Dipstick |
| K993203 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
06/28/2007 |
| eScreen, Inc. mCheck Multi-Line Screen Test Device |
| K050050 |
Amphetamines |
Toxicology / TDM |
06/28/2007 |
| eScreen, Inc. mCheck Multi-Line Screen Test Device |
| K050050 |
Cannabinoids (THC) |
Toxicology / TDM |
06/28/2007 |
| eScreen, Inc. mCheck Multi-Line Screen Test Device |
| K050050 |
Phencyclidine (PCP) |
Toxicology / TDM |
06/28/2007 |
| eScreen, Inc. mCheck Multi-Line Screen Test Device |
| K050050 |
Cocaine Metabolites |
Toxicology / TDM |
06/28/2007 |
| eScreen, Inc. mCheck Multi-Line Screen Test Device |
| K050050 |
Opiates |
Toxicology / TDM |
06/28/2007 |
| eScreen, Inc. mCheck Multi-Line Screen Test Device |
| K050050 |
Methamphetamines |
Toxicology / TDM |
06/28/2007 |
| Physicians Medical Supply Quick Chek Blood Glucose Monitoring System |
| K063212 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/28/2007 |
| PSS World Medical Select Diagnostics Strep A Twist |
| K023766 |
Streptococcus, Group A |
Bacteriology |
06/28/2007 |
| Tyson Bioresearch, Inc. EZ Smart-608 Blood Glucose Monitoring System |
| K062829 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/28/2007 |
| Cambridge Sensors ltd. microdot Blood Glucose Monitoring System |
| K070524 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/25/2007 |
| Kurkel Enterprises Early-Pregnancy-Tests.com Ovulation Midstream Tests |
| X050002 |
Ovulation Test (LH) By Visual Color Comparison |
Endocrinology |
06/25/2007 |
| Kurkel Enterprises Early-Pregnancy-Tests.com Ovulation Test Strips |
| X050002 |
Ovulation Test (LH) By Visual Color Comparison |
Endocrinology |
06/25/2007 |
| PSS World Medical Select Diagnostics Strep A Dipstick |
| K010582 |
Streptococcus, Group A |
Bacteriology |
06/25/2007 |
| Rush Industries Ovulation Test |
| X050002 |
Ovulation Test (LH) By Visual Color Comparison |
Endocrinology |
06/25/2007 |
| Select Medical Products Brand Rapid Test H. Pylori {Whole Blood Only} (H. Pylori) |
| K024350 |
Helicobacter Pylori Antibodies |
General Immunology |
06/25/2007 |
| Fertell Male Fertility Test |
| K041039 |
Semen |
Hematology |
06/18/2007 |
| Nova Biomedical Nova Max Blood Glucose Monitoring System |
| K070255 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/18/2007 |
| Fisher Healthcare Sure-Vue H. pylori Test (Whole Blood) |
| K024350 |
Helicobacter Pylori Antibodies |
General Immunology |
06/11/2007 |
| Inverness Medical Profesional Diagnostics Signify H. pylori Test (Whole Blood) |
| K024350 |
Helicobacter Pylori Antibodies |
General Immunology |
06/11/2007 |
| McKesson Medi-Lab Performance H. pylori Test (Whole Blood) |
| K024350 |
Helicobacter Pylori Antibodies |
General Immunology |
06/11/2007 |
| Savyon Diagnostics Uriscreen {Bacteriuria} |
| K882211 |
Urine Dipstick Or Tablet Analytes, Nonautomated |
Urinalysis |
06/11/2007 |
| PSS World Medical Select hCG Cassette |
| K041728 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
06/01/2007 |
| PSS World Medical Select hCG Combo |
| K041728 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
06/01/2007 |
| PSS World Medical Select hCG Dipstick |
| K041728 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
06/01/2007 |
| Arkray SPOTCHEM EZ Chemistry Analyzer (Whole Blood) |
| K050652 |
Creatinine |
General Chemistry |
05/31/2007 |
| Arkray SPOTCHEM EZ Chemistry Analyzer (Whole Blood) |
| K053401 |
Protein, Total |
General Chemistry |
05/31/2007 |
| Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 1} (Whole Blood) |
| K053401 |
Albumin |
General Chemistry |
05/31/2007 |
| Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 1} (Whole Blood) |
| K053401 |
Calcium, Total |
General Chemistry |
05/31/2007 |
| Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 1} (Whole Blood) |
| K053401 |
Glucose |
General Chemistry |
05/31/2007 |
| Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 1} (Whole Blood) |
| K053401 |
Creatinine |
General Chemistry |
05/31/2007 |
| Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 1} (Whole Blood) |
| K053401 |
Urea (BUN) |
General Chemistry |
05/31/2007 |
| Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 2} (Whole Blood) |
| K053401 |
Protein, Total |
General Chemistry |
05/31/2007 |
| Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 2} (Whole Blood) |
| K053401 |
Alanine Aminotransferase (ALT) (SGPT) |
General Chemistry |
05/31/2007 |
| Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 2} (Whole Blood) |
| K053401 |
Aspartate Aminotransferase (AST) (SGOT) |
General Chemistry |
05/31/2007 |
| Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 2} (Whole Blood) |
| K053401 |
Alkaline Phosphatase (ALP) |
General Chemistry |
05/31/2007 |
| Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 2} (Whole Blood) |
| K053401 |
Bilirubin, Total |
General Chemistry |
05/31/2007 |
| Cardinal Health, SP Brand Rapid Test Mono (Whole Blood) |
| K042272 |
Infectious Mononucleosis Antibodies (Mono) |
General Immunology |
05/31/2007 |
| Roche Diagnostics Corp. ACCU-CHEK Performa System |
| K070585 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
05/31/2007 |
| SA Scientific SAS Pregnancy Serum/Urine Test |
| K010593 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
05/31/2007 |
| Cardinal Health SP Brand Rapid Test H. Pylori {H. Pylori} (Whole Blood) |
| K024350 |
Helicobacter Pylori Antibodies |
General Immunology |
05/24/2007 |
| Cardinal Health SP Brand Rapid Test Strep A Dipstick |
| K010582 |
Streptococcus, Group A |
Bacteriology |
05/24/2007 |
| Innovacon Multi-Clin Drug Screen Test Device |
| K041685 |
Amphetamines |
Toxicology / TDM |
05/24/2007 |
| Innovacon Multi-Clin Drug Screen Test Device |
| K041685 |
Cannabinoids (THC) |
Toxicology / TDM |
05/24/2007 |
| Innovacon Multi-Clin Drug Screen Test Device |
| K041685 |
Phencyclidine (PCP) |
Toxicology / TDM |
05/24/2007 |
| Innovacon Multi-Clin Drug Screen Test Device |
| K041685 |
Cocaine Metabolites |
Toxicology / TDM |
05/24/2007 |
| Innovacon Multi-Clin Drug Screen Test Device |
| K041685 |
Opiates |
Toxicology / TDM |
05/24/2007 |
| Innovacon Multi-Clin Drug Screen Test Device |
| K041685 |
Propoxyphene |
Toxicology / TDM |
05/24/2007 |
| Innovacon Multi-Clin Drug Screen Test Device |
| K041685 |
Benzodiazepines |
Toxicology / TDM |
05/24/2007 |
| Innovacon Multi-Clin Drug Screen Test Device |
| K041685 |
Barbiturates |
Toxicology / TDM |
05/24/2007 |
| Innovacon Multi-Clin Drug Screen Test Device |
| K041685 |
Tricyclic Antidepressants |
Toxicology / TDM |
05/24/2007 |
| Innovacon Multi-Clin Drug Screen Test Device |
| K041685 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
05/24/2007 |
| Innovacon Multi-Clin Drug Screen Test Device |
| K041685 |
Oxycodone |
Toxicology / TDM |
05/24/2007 |
| Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device |
| K041685 |
Amphetamines |
Toxicology / TDM |
05/24/2007 |
| Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device |
| K041685 |
Cannabinoids (THC) |
Toxicology / TDM |
05/24/2007 |
| Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device |
| K041685 |
Phencyclidine (PCP) |
Toxicology / TDM |
05/24/2007 |
| Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device |
| K041685 |
Cocaine Metabolites |
Toxicology / TDM |
05/24/2007 |
| Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device |
| K041685 |
Opiates |
Toxicology / TDM |
05/24/2007 |
| Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device |
| K041685 |
Propoxyphene |
Toxicology / TDM |
05/24/2007 |
| Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device |
| K041685 |
Benzodiazepines |
Toxicology / TDM |
05/24/2007 |
| Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device |
| K041685 |
Barbiturates |
Toxicology / TDM |
05/24/2007 |
| Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device |
| K041685 |
Tricyclic Antidepressants |
Toxicology / TDM |
05/24/2007 |
| Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device |
| K041685 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
05/24/2007 |
| Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device |
| K041685 |
Oxycodone |
Toxicology / TDM |
05/24/2007 |
| Immuno Detector Mono {Whole Blood} |
| K961024 |
Infectious Mononucleosis Antibodies (Mono) |
General Immunology |
05/17/2007 |
| Cholestech LDX {Lipid Profile - ALT (GPT)} (Whole Blood) |
| K922612 |
Alanine Aminotransferase (ALT) (SGPT) |
General Chemistry |
05/16/2007 |
| Cholestech LDX {Lipid Profile - ALT (GPT)} (Whole Blood) |
| K922612 |
Triglyceride |
General Chemistry |
05/16/2007 |
| Cholestech LDX {Lipid Profile - ALT (GPT)} (Whole Blood) |
| K922612 |
HDL Cholesterol |
General Chemistry |
05/16/2007 |
| Cholestech LDX {Lipid Profile - ALT (GPT)} (Whole Blood) |
| K922612 |
Cholesterol |
General Chemistry |
05/16/2007 |
| Forsure One Step Fecal Occult Blood (FOB) Screen Card Test |
| K063693 |
Fecal Occult Blood |
General Chemistry |
05/16/2007 |
| Immunostics Detector H. pylori WB {H. pylori Antiboby Test} (For whole blood) |
| K980798 |
Helicobacter Pylori Antibodies |
General Immunology |
05/16/2007 |
| KoreaMedico Chextic |
| K062096 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
05/10/2007 |
| McKesson Medi-Lab Performance Strep A Test - Twist |
| K023766 |
Streptococcus, Group A |
Bacteriology |
05/10/2007 |
| PerMaxim RediScreen Strep A Twist Cassette |
| K023766 |
Streptococcus, Group A |
Bacteriology |
05/10/2007 |
| AmeriTek USA, dBest One Step hCG Panel Test Kit |
| K061257 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
05/07/2007 |
| Church & Dwight Co., Inc. FIRST RESPONSE Gold Digital Pregnancy Test |
| K070054 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
05/07/2007 |
| Diacare Corp. EASY CHECK Blood Glucose Monitoring System |
| K062538 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
05/02/2007 |
| Taidoc Technology easi check precise Blood Glucose Monitoring System |
| K042005 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
05/02/2007 |
| Abbott Diabetes Care Inc., FreeStyle Lite Glucose Monitoring System |
| K070850 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
04/12/2007 |
| BTNX Inc. Rapid Response Blood Glucose Monitoring System |
| K051854 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
04/12/2007 |
| Clearview MONO Whole Blood (Whole Blood) |
| K042272 |
Infectious Mononucleosis Antibodies (Mono) |
General Immunology |
04/12/2007 |
| Diabetic Supply of Suncoast, Inc. Advocate Duo Blood Glucose Plus Blood Pressure Monitoring System |
| K070641 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
04/12/2007 |
| HemoCue Hb 301 System |
| K061047 |
Hemoglobin |
Hematology |
04/12/2007 |
| Medi-Lab Performance Infectious Mononucleosis Test (Whole Blood) |
| K042272 |
Infectious Mononucleosis Antibodies (Mono) |
General Immunology |
04/12/2007 |
| Signify Mono Whole Blood (Whole Blood) |
| K042272 |
Infectious Mononucleosis Antibodies (Mono) |
General Immunology |
04/12/2007 |
| Fisher HealthCare Sure-Vue Serum/Urine hCG-STAT |
| K062361 |
hCG, Urine |
Endocrinology |
04/02/2007 |
| Jant Pharmacal Corporation Accutest TSH (Whole Blood) |
| K990658 |
Thyroid Stimulating Hormone (TSH) |
Endocrinology |
04/02/2007 |
| Bionime Corporation Rightest Blood Glucose Monitoring System |
| K062567 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/29/2007 |
| Fisher HealthCare Sure-Vue Urine hCG |
| K993317 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
03/29/2007 |
| Redwood Toxicology Laboratory Reditest Home Drug Test |
| K050878 |
Amphetamines |
Toxicology / TDM |
03/29/2007 |
| Redwood Toxicology Laboratory Reditest Home Drug Test |
| K050878 |
Cannabinoids (THC) |
Toxicology / TDM |
03/29/2007 |
| Redwood Toxicology Laboratory Reditest Home Drug Test |
| K050878 |
Phencyclidine (PCP) |
Toxicology / TDM |
03/29/2007 |
| Redwood Toxicology Laboratory Reditest Home Drug Test |
| K050878 |
Cocaine Metabolites |
Toxicology / TDM |
03/29/2007 |
| Redwood Toxicology Laboratory Reditest Home Drug Test |
| K050878 |
Opiates |
Toxicology / TDM |
03/29/2007 |
| Redwood Toxicology Laboratory Reditest Home Drug Test |
| K050878 |
Methamphetamines |
Toxicology / TDM |
03/29/2007 |
| Redwood Toxicology Laboratory Reditest Home Drug Test |
| K050878 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
03/29/2007 |
| Fisher HealthCare Sure-Vue Serum/Urine hCG |
| K993065 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
03/28/2007 |
| Fisher HealthCare Sure-Vue Strep A Test |
| K010582 |
Streptococcus, Group A |
Bacteriology |
03/28/2007 |
| Home Diagnostics, TRUEread Blood Glucose Monitoring System |
| K042080 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/28/2007 |
| Mckesson Medi-Lab Strep A Test - Dipstick |
| K010582 |
Streptococcus, Group A |
Bacteriology |
03/28/2007 |
| McKesson Medical-Surgical Medi-Lab Performance hCG Combo Test-Cassette |
| K993065 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
03/28/2007 |
| SA Scientific SAS Pregnancy Urine Test |
| K010522 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
03/28/2007 |
| Roche Diagnostics CoaguChek XS |
| K060978 |
Prothrombin Time (PT) |
Hematology |
03/23/2007 |
| Kurkel Enterprises Early-Pregnancy-Tests.com Pregnancy Midstream Tests |
| K974059 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
03/19/2007 |
| Kurkel Enterprises Early-Pregnancy-Tests.com Pregnancy Test Strips |
| K951705 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
03/19/2007 |
| Rush Industries Rush Pregnancy Test |
| K974059 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
03/19/2007 |
| TaiDoc Clever Chek Blood Glucose Monitoring System TD-4230 |
| K070472 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/19/2007 |
| TaiDoc SureChek Blood Glucose Monitoring System |
| K070472 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/19/2007 |
| Bayer Clinitek Status Urine Chemistry Analyzer |
| K032563 |
hCG, Urine |
Endocrinology |
03/16/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) |
| K950164 |
Calcium, Total |
General Chemistry |
03/14/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) |
| K934592 |
Uric Acid |
General Chemistry |
03/14/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) |
| K942782 |
Albumin |
General Chemistry |
03/14/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) |
| K942782 |
Protein, Total |
General Chemistry |
03/14/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) |
| K942782 |
Aspartate Aminotransferase (AST) (SGOT) |
General Chemistry |
03/14/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) |
| K942782 |
Glucose |
General Chemistry |
03/14/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) |
| K942782 |
Creatinine |
General Chemistry |
03/14/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) |
| K942782 |
Urea (BUN) |
General Chemistry |
03/14/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) |
| K942782 |
Bilirubin, Total |
General Chemistry |
03/14/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood) |
| K942782 |
Aspartate Aminotransferase (AST) (SGOT) |
General Chemistry |
03/14/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood) |
| K942782 |
Glucose |
General Chemistry |
03/14/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood) |
| K942782 |
Creatinine |
General Chemistry |
03/14/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood) |
| K942782 |
Urea (BUN) |
General Chemistry |
03/14/2007 |
| Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood) |
| K942782 |
Aspartate Aminotransferase (AST) (SGOT) |
General Chemistry |
03/14/2007 |
| Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood) |
| K942782 |
Glucose |
General Chemistry |
03/14/2007 |
| Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood) |
| K942782 |
Creatinine |
General Chemistry |
03/14/2007 |
| Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood) |
| K942782 |
Urea (BUN) |
General Chemistry |
03/14/2007 |
| Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) |
| K942782 |
Albumin |
General Chemistry |
03/14/2007 |
| Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) |
| K942782 |
Protein, Total |
General Chemistry |
03/14/2007 |
| Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) |
| K942782 |
Aspartate Aminotransferase (AST) (SGOT) |
General Chemistry |
03/14/2007 |
| Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) |
| K942782 |
Glucose |
General Chemistry |
03/14/2007 |
| Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) |
| K942782 |
Creatinine |
General Chemistry |
03/14/2007 |
| Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) |
| K942782 |
Urea (BUN) |
General Chemistry |
03/14/2007 |
| Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) |
| K942782 |
Bilirubin, Total |
General Chemistry |
03/14/2007 |
| Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) |
| K934592 |
Uric Acid |
General Chemistry |
03/14/2007 |
| Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) |
| K950164 |
Calcium, Total |
General Chemistry |
03/14/2007 |
| Redwood Toxicology Laboratory Reditest 6 Cassette substance abuse screening device (Professional Use) |
| K050050 |
Amphetamines |
Toxicology / TDM |
03/14/2007 |
| Redwood Toxicology Laboratory Reditest 6 Cassette substance abuse screening device (Professional Use) |
| K050050 |
Cannabinoids (THC) |
Toxicology / TDM |
03/14/2007 |
| Redwood Toxicology Laboratory Reditest 6 Cassette substance abuse screening device (Professional Use) |
| K050050 |
Phencyclidine (PCP) |
Toxicology / TDM |
03/14/2007 |
| Redwood Toxicology Laboratory Reditest 6 Cassette substance abuse screening device (Professional Use) |
| K050050 |
Cocaine Metabolites |
Toxicology / TDM |
03/14/2007 |
| Redwood Toxicology Laboratory Reditest 6 Cassette substance abuse screening device (Professional Use) |
| K050050 |
Opiates |
Toxicology / TDM |
03/14/2007 |
| Redwood Toxicology Laboratory Reditest 6 Cassette substance abuse screening device (Professional Use) |
| K050050 |
Methamphetamines |
Toxicology / TDM |
03/14/2007 |
| SA Scientific SAS Pregnancy Serum/Urine Test |
| K010593 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
03/14/2007 |
| Fisher HealthCare Sure-Vue Urine hCG Strip |
| K993203 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
03/07/2007 |
| Innovacon FOB Flipcard Fecal Occult Blood Test |
| K063673 |
Fecal Occult Blood |
General Chemistry |
03/07/2007 |
| McKesson Medical-Surgical, Medi-Lab Performance hCG Urine Test - Cassette |
| K993317 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
03/07/2007 |
| McKesson Medical-Surgical, Medi-Lab Performance hCG Urine Test - Dipstick |
| K993203 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
03/07/2007 |
| Tyson Bioresearch, Inc. SMARTCHEX Blood Glucose Monitoring System |
| K052818 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/07/2007 |
| Roche Diagnostics Accu-Chek Inform System (Professional Use) |
| K003846 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
02/26/2007 |
| Roche Diagnostics CoaguChek XS PST |
| K062925 |
Prothrombin Time (PT) |
Hematology |
02/26/2007 |
| Apex Biotechnology Corp. Assure 4 Blood Glucose Monitoring System |
| K070088 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
02/22/2007 |
| Innovacon Integrated E-Z Split Key Cup II (Professional Use) |
| K050878 |
Amphetamines |
Toxicology / TDM |
02/22/2007 |
| Innovacon Integrated E-Z Split Key Cup II (Professional Use) |
| K050878 |
Cannabinoids (THC) |
Toxicology / TDM |
02/22/2007 |
| Innovacon Integrated E-Z Split Key Cup II (Professional Use) |
| K050878 |
Phencyclidine (PCP) |
Toxicology / TDM |
02/22/2007 |
| Innovacon Integrated E-Z Split Key Cup II (Professional Use) |
| K050878 |
Cocaine Metabolites |
Toxicology / TDM |
02/22/2007 |
| Innovacon Integrated E-Z Split Key Cup II (Professional Use) |
| K050878 |
Opiates |
Toxicology / TDM |
02/22/2007 |
| Innovacon Integrated E-Z Split Key Cup II (Professional Use) |
| K050878 |
Methamphetamines |
Toxicology / TDM |
02/22/2007 |
| Innovacon Integrated E-Z Split Key Cup II (Professional Use) |
| K050878 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
02/22/2007 |
| Inverness Medical Professional Devices Clearview hCG Urine Cassette |
| K993317 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
02/13/2007 |
| Inverness Medical Professional Diagnostics Clearview hCG Combo II |
| K993065 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
02/13/2007 |
| Inverness Medical Professional Diagnostics Clearview hCG Urine Dipstick |
| K993203 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
02/13/2007 |
| Inverness Medical Professional Diagnostics Signify hCG Combo Urine/Serum |
| K993065 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
02/13/2007 |
| Inverness Medical Professional Diagnostics Signify hCG Urine Cassette |
| K993317 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
02/13/2007 |
| Inverness Medical Professional Diagnostics Signify hCG Urine Dipstick |
| K993203 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
02/13/2007 |
| Ok Biotech Co., Ltd. Ok Meter Blood Glucose Monitoring System |
| K063026 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
02/13/2007 |
| Inverness Medical Clearview Strep A Exact II Dipstick |
| K010582 |
Streptococcus, Group A |
Bacteriology |
02/08/2007 |
| Select Diagnostics Immunochemical Fecal Occult Blood Test |
| K060463 |
Fecal Occult Blood |
General Chemistry |
02/08/2007 |
| Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis |
| K023885 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
02/07/2007 |
| Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis |
| K023885 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
02/07/2007 |
| Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis |
| K023885 |
Urine Qualitative Dipstick Blood |
Urinalysis |
02/07/2007 |
| Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis |
| K023885 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
02/07/2007 |
| Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis |
| K023885 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
02/07/2007 |
| Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis |
| K023885 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
02/07/2007 |
| Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis |
| K023885 |
Urine Qualitative Dipstick pH |
Urinalysis |
02/07/2007 |
| Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis |
| K023885 |
Urine Qualitative Dipstick Protein |
Urinalysis |
02/07/2007 |
| Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis |
| K023885 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
02/07/2007 |
| Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis |
| K023885 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
02/07/2007 |
| Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis |
| K023885 |
Urine Qualitative Dipstick Ascorbic Acid |
Urinalysis |
02/07/2007 |
| Inverness Medical Clearview H. pylori Test (Whole Blood) |
| K024350 |
Helicobacter Pylori Antibodies |
General Immunology |
02/07/2007 |
| Polymer Technology Systems CardioChek Analyzer {PTS PANELS Metabolic Chemistry Panel Test Strips} |
| K070017 |
Triglyceride |
General Chemistry |
02/07/2007 |
| Polymer Technology Systems CardioChek Analyzer {PTS PANELS Metabolic Chemistry Panel Test Strips} |
| K070017 |
HDL Cholesterol |
General Chemistry |
02/07/2007 |
| Polymer Technology Systems CardioChek Analyzer {PTS PANELS Metabolic Chemistry Panel Test Strips} |
| K070017 |
Glucose |
General Chemistry |
02/07/2007 |
| Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS Metabolic Chemistry Panel Test Strips} |
| K070017 |
Triglyceride |
General Chemistry |
02/07/2007 |
| Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS Metabolic Chemistry Panel Test Strips} |
| K070017 |
HDL Cholesterol |
General Chemistry |
02/07/2007 |
| Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS Metabolic Chemistry Panel Test Strips} |
| K070017 |
Glucose |
General Chemistry |
02/07/2007 |
| Apex Biotechnology Corp. Gluco Track Blood Glucose Monitoring System |
| K062799 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
02/05/2007 |
| TaiDoc Advocate Blood Glucose Monitoring System |
| K063212 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
01/31/2007 |
| Teco Diagnostics Microalbumin 2-1 Combo Strip |
| K061419 |
Urine Qualitative Dipstick Protein |
Urinalysis |
01/29/2007 |
| Teco Diagnostics Microalbumin 2-1 Combo Strip |
| K061419 |
Urine Qualitative Dipstick Creatinine |
Urinalysis |
01/29/2007 |
| EUKARE Blood Glucose Monitoring System |
| K062892 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
01/26/2007 |
| InSure Quik Fecal Immunochemical Test (F.I.T.) |
| K060930 |
Fecal Occult Blood |
General Chemistry |
01/26/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood) |
| K950164 |
Alanine Aminotransferase (ALT) (SGPT) |
General Chemistry |
01/22/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) |
| K950164 |
Alkaline Phosphatase (ALP) |
General Chemistry |
01/22/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) |
| K950164 |
Amylase |
General Chemistry |
01/22/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) |
| K950164 |
Alanine Aminotransferase (ALT) (SGPT) |
General Chemistry |
01/22/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood) |
| K955770 |
Gamma Glutamyl Transferase (GGT) |
General Chemistry |
01/22/2007 |
| Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) |
| K955770 |
Gamma Glutamyl Transferase (GGT) |
General Chemistry |
01/22/2007 |
| Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) |
| K955770 |
Gamma Glutamyl Transferase (GGT) |
General Chemistry |
01/22/2007 |
| Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood) |
| K955770 |
Gamma Glutamyl Transferase (GGT) |
General Chemistry |
01/22/2007 |
| Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) |
| K950164 |
Alanine Aminotransferase (ALT) (SGPT) |
General Chemistry |
01/22/2007 |
| Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood) |
| K950164 |
Alanine Aminotransferase (ALT) (SGPT) |
General Chemistry |
01/22/2007 |
| Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) |
| K950164 |
Alkaline Phosphatase (ALP) |
General Chemistry |
01/22/2007 |
| Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) |
| K950164 |
Amylase |
General Chemistry |
01/22/2007 |
| Abaxis, Piccolo xpress Chemistry Analyzer |
| K950164 |
Alanine Aminotransferase (ALT) (SGPT) |
General Chemistry |
01/22/2007 |
| Abaxis, Piccolo xpress Chemistry Analyzer |
| K950164 |
Alkaline Phosphatase (ALP) |
General Chemistry |
01/22/2007 |
| Abaxis, Piccolo xpress Chemistry Analyzer |
| K950164 |
Amylase |
General Chemistry |
01/22/2007 |
| Abaxis, Piccolo xpress Chemistry Analyzer |
| K955770 |
Gamma Glutamyl Transferase (GGT) |
General Chemistry |
01/22/2007 |
| Abaxis, Piccolo xpress Chemistry Analyzer |
| K942782 |
Albumin |
General Chemistry |
01/22/2007 |
| Abaxis, Piccolo xpress Chemistry Analyzer |
| K942782 |
Protein, Total |
General Chemistry |
01/22/2007 |
| Abaxis, Piccolo xpress Chemistry Analyzer |
| K942782 |
Aspartate Aminotransferase (AST) (SGOT) |
General Chemistry |
01/22/2007 |
| Abaxis, Piccolo xpress Chemistry Analyzer |
| K942782 |
Glucose |
General Chemistry |
01/22/2007 |
| Abaxis, Piccolo xpress Chemistry Analyzer |
| K942782 |
Bilirubin, Total |
General Chemistry |
01/22/2007 |
| Abaxis, Piccolo xpress Chemistry Analyzer |
| K023639 |
Triglyceride |
General Chemistry |
01/22/2007 |
| Abaxis, Piccolo xpress Chemistry Analyzer |
| K023640 |
HDL Cholesterol |
General Chemistry |
01/22/2007 |
| Abaxis, Piccolo xpress Chemistry Analyzer |
| K023642 |
Cholesterol |
General Chemistry |
01/22/2007 |
| Taidoc Technology Corporation Clever Chek TD-3213 Blood Glucose Plus Blood Pressure Monitoring System |
| K062800 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
01/18/2007 |
| Taidoc Technology Corporation Clever Chek TD-3215 Blood Glucose Plus Blood Pressure Monitoring System |
| K062800 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
01/18/2007 |
| Taidoc Technology Corporation Clever Chek TD-3217 Blood Glucose Plus Blood Pressure Monitoring System |
| K062800 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
01/18/2007 |
| Taidoc Technology Corporation Clever Chek TD-3250 Blood Glucose Plus Blood Pressure Monitoring System |
| K062800 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
01/18/2007 |
| Taidoc Technology Corporation Dr. T TD-3216 Blood Glucose Plus Blood Pressure Monitoring System |
| K062800 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
01/18/2007 |
| US Diagnostics, Inc. EASYGLUCO Glucose Monitoring System |
| K061431 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
01/18/2007 |
| Natureplex, LLC BE CERTAIN Home Pregnancy Test |
| K051963 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
01/12/2007 |
| Arkray, Ferrara Blood Glucose Monitoring System |
| K063068 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
01/09/2007 |
| Common Sense Ltd. Fem-V Test Kit |
| K043109 |
Vaginal pH |
General Chemistry |
01/09/2007 |
| Henry Schein Urispec 4-Way Reagent Test Strips |
| K991927 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
01/09/2007 |
| Henry Schein Urispec 4-Way Reagent Test Strips |
| K991927 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
01/09/2007 |
| Henry Schein Urispec 4-Way Reagent Test Strips |
| K991927 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
01/09/2007 |
| Henry Schein Urispec 4-Way Reagent Test Strips |
| K991927 |
Urine Qualitative Dipstick Protein |
Urinalysis |
01/09/2007 |
| LifeSign, LLC Status hCG Strip |
| K950307 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
01/09/2007 |
| ARJ Medical URITEST 10 Reagent Strips for Urinalysis |
| K052719 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
12/30/2006 |
| ARJ Medical URITEST 10 Reagent Strips for Urinalysis |
| K052719 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
12/30/2006 |
| ARJ Medical URITEST 10 Reagent Strips for Urinalysis |
| K052719 |
Urine Qualitative Dipstick Blood |
Urinalysis |
12/30/2006 |
| ARJ Medical URITEST 10 Reagent Strips for Urinalysis |
| K052719 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
12/30/2006 |
| ARJ Medical URITEST 10 Reagent Strips for Urinalysis |
| K052719 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
12/30/2006 |
| ARJ Medical URITEST 10 Reagent Strips for Urinalysis |
| K052719 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
12/30/2006 |
| ARJ Medical URITEST 10 Reagent Strips for Urinalysis |
| K052719 |
Urine Qualitative Dipstick pH |
Urinalysis |
12/30/2006 |
| ARJ Medical URITEST 10 Reagent Strips for Urinalysis |
| K052719 |
Urine Qualitative Dipstick Protein |
Urinalysis |
12/30/2006 |
| ARJ Medical URITEST 10 Reagent Strips for Urinalysis |
| K052719 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
12/30/2006 |
| ARJ Medical URITEST 10 Reagent Strips for Urinalysis |
| K052719 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
12/30/2006 |
| Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup |
| K050878 |
Amphetamines |
Toxicology / TDM |
12/28/2006 |
| Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup |
| K050878 |
Cannabinoids (THC) |
Toxicology / TDM |
12/28/2006 |
| Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup |
| K050878 |
Phencyclidine (PCP) |
Toxicology / TDM |
12/28/2006 |
| Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup |
| K050878 |
Cocaine Metabolites |
Toxicology / TDM |
12/28/2006 |
| Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup |
| K050878 |
Opiates |
Toxicology / TDM |
12/28/2006 |
| Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup |
| K050878 |
Methamphetamines |
Toxicology / TDM |
12/28/2006 |
| Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup |
| K050878 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
12/28/2006 |
| Wolfe Drug Testing RealityCheck Integrated Specimen Cup |
| K050878 |
Amphetamines |
Toxicology / TDM |
12/28/2006 |
| Wolfe Drug Testing RealityCheck Integrated Specimen Cup |
| K050878 |
Cannabinoids (THC) |
Toxicology / TDM |
12/28/2006 |
| Wolfe Drug Testing RealityCheck Integrated Specimen Cup |
| K050878 |
Phencyclidine (PCP) |
Toxicology / TDM |
12/28/2006 |
| Wolfe Drug Testing RealityCheck Integrated Specimen Cup |
| K050878 |
Cocaine Metabolites |
Toxicology / TDM |
12/28/2006 |
| Wolfe Drug Testing RealityCheck Integrated Specimen Cup |
| K050878 |
Opiates |
Toxicology / TDM |
12/28/2006 |
| Wolfe Drug Testing RealityCheck Integrated Specimen Cup |
| K050878 |
Methamphetamines |
Toxicology / TDM |
12/28/2006 |
| Wolfe Drug Testing RealityCheck Integrated Specimen Cup |
| K050878 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
12/28/2006 |
| Arkray SPOTCHEM EZ Chemistry Analyzer {Lipid Panel} (Whole Blood) |
| K042443 |
Triglyceride |
General Chemistry |
12/12/2006 |
| Arkray SPOTCHEM EZ Chemistry Analyzer {Lipid Panel} (Whole Blood) |
| K042443 |
HDL Cholesterol |
General Chemistry |
12/12/2006 |
| Arkray SPOTCHEM EZ Chemistry Analyzer {Lipid Panel} (Whole Blood) |
| K042443 |
Cholesterol |
General Chemistry |
12/12/2006 |
| Taidoc Clever Chek Blood Glucose Monitoring System TD-4223 |
| K063212 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
11/29/2006 |
| Taidoc Clever Chek Blood Glucose Monitoring System TD-4231 |
| K063212 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
11/29/2006 |
| Bayer Diagnostics Ascencia BREEZE 2 Blood Glucose Monitoring System |
| K062347 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
11/22/2006 |
| LifeSign Status Mono (For whole blood) |
| K961024 |
Infectious Mononucleosis Antibodies (Mono) |
General Immunology |
11/22/2006 |
| All Medicus GlucoDr SuperSensor Blood Glucose Test System |
| K050985 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
11/20/2006 |
| Chembio HIV 1/2 STAT-PAK Assay (Fingerstick, Venipuncture Whole Blood) |
| BP050010 |
HIV Antibodies |
General Immunology |
11/20/2006 |
| Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC) |
| K023489 |
Amphetamines |
Toxicology / TDM |
11/14/2006 |
| Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC) |
| K023489 |
Cannabinoids (THC) |
Toxicology / TDM |
11/14/2006 |
| Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC) |
| K023489 |
Phencyclidine (PCP) |
Toxicology / TDM |
11/14/2006 |
| Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC) |
| K023489 |
Cocaine Metabolites |
Toxicology / TDM |
11/14/2006 |
| Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC) |
| K023489 |
Opiates |
Toxicology / TDM |
11/14/2006 |
| Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC) |
| K023489 |
Methadone |
Toxicology / TDM |
11/14/2006 |
| Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC) |
| K023489 |
Methamphetamines |
Toxicology / TDM |
11/14/2006 |
| Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC) |
| K023489 |
Benzodiazepines |
Toxicology / TDM |
11/14/2006 |
| Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC) |
| K023489 |
Barbiturates |
Toxicology / TDM |
11/14/2006 |
| Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC) |
| K023489 |
Tricyclic Antidepressants |
Toxicology / TDM |
11/14/2006 |
| Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC) |
| K023489 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
11/14/2006 |
| Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC) |
| K023489 |
Oxycodone |
Toxicology / TDM |
11/14/2006 |
| Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC) |
| K022355 |
Amphetamines |
Toxicology / TDM |
11/14/2006 |
| Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC) |
| K022355 |
Cannabinoids (THC) |
Toxicology / TDM |
11/14/2006 |
| Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC) |
| K022355 |
Phencyclidine (PCP) |
Toxicology / TDM |
11/14/2006 |
| Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC) |
| K022355 |
Cocaine Metabolites |
Toxicology / TDM |
11/14/2006 |
| Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC) |
| K022355 |
Opiates |
Toxicology / TDM |
11/14/2006 |
| Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC) |
| K022355 |
Methadone |
Toxicology / TDM |
11/14/2006 |
| Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC) |
| K022355 |
Methamphetamines |
Toxicology / TDM |
11/14/2006 |
| Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC) |
| K022355 |
Benzodiazepines |
Toxicology / TDM |
11/14/2006 |
| Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC) |
| K022355 |
Barbiturates |
Toxicology / TDM |
11/14/2006 |
| Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC) |
| K022355 |
Tricyclic Antidepressants |
Toxicology / TDM |
11/14/2006 |
| Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC) |
| K022355 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
11/14/2006 |
| Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC) |
| K022355 |
Oxycodone |
Toxicology / TDM |
11/14/2006 |
| Inverness Medical - BioStar Inc. Acceava hCG Basic II |
| K993203 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
11/14/2006 |
| Planned Parenthood hCG Pregnancy Test Dipstick |
| K993203 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
11/14/2006 |
| Planned Parenthood hCG Pregnancy Test One Step Cassette |
| K993317 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
11/14/2006 |
| Bayer Clinitek Status Urine Chemistry Analyzer |
| K031947 |
Microalbumin |
General Chemistry |
11/01/2006 |
| BioStar Acceava Mono II (Whole Blood) |
| K042272 |
Infectious Mononucleosis Antibodies (Mono) |
General Immunology |
11/01/2006 |
| BTNX Inc Rapid Response H. pylori Rapid Test Device (Whole Blood) |
| K024350 |
Helicobacter Pylori Antibodies |
General Immunology |
11/01/2006 |
| GlucoPlus Inc. GlucoPlus Blood Glucose Monitoring System |
| K061234 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
11/01/2006 |
| Innovacon hCG Ultra Test Device |
| K062361 |
hCG, Urine |
Endocrinology |
11/01/2006 |
| Inverness Medical BioStar Acceava Strep A Test |
| K010582 |
Streptococcus, Group A |
Bacteriology |
11/01/2006 |
| BTNX Inc. Rapid Response 11 Parameters Ultra |
| K023885 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
10/27/2006 |
| BTNX Inc. Rapid Response 11 Parameters Ultra |
| K023885 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
10/27/2006 |
| BTNX Inc. Rapid Response 11 Parameters Ultra |
| K023885 |
Urine Qualitative Dipstick Blood |
Urinalysis |
10/27/2006 |
| BTNX Inc. Rapid Response 11 Parameters Ultra |
| K023885 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
10/27/2006 |
| BTNX Inc. Rapid Response 11 Parameters Ultra |
| K023885 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
10/27/2006 |
| BTNX Inc. Rapid Response 11 Parameters Ultra |
| K023885 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
10/27/2006 |
| BTNX Inc. Rapid Response 11 Parameters Ultra |
| K023885 |
Urine Qualitative Dipstick pH |
Urinalysis |
10/27/2006 |
| BTNX Inc. Rapid Response 11 Parameters Ultra |
| K023885 |
Urine Qualitative Dipstick Protein |
Urinalysis |
10/27/2006 |
| BTNX Inc. Rapid Response 11 Parameters Ultra |
| K023885 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
10/27/2006 |
| BTNX Inc. Rapid Response 11 Parameters Ultra |
| K023885 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
10/27/2006 |
| BTNX Inc. Rapid Response 11 Parameters Ultra |
| K023885 |
Urine Qualitative Dipstick Ascorbic Acid |
Urinalysis |
10/27/2006 |
| AgaMatrix GRACEpro Blood Glucose Monitoring System |
| K052762 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
10/20/2006 |
| AgaMatrix KeyNote Blood Glucose Monitoring System |
| K052762 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
10/20/2006 |
| Clarity H. pylori Rapid Test Device (Whole Blood) |
| K024350 |
Helicobacter Pylori Antibodies |
General Immunology |
10/20/2006 |
| Tyson Bioresearch Inc. DIACHEX Blood Glucose Monitoring System |
| K062829 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
10/20/2006 |
| Genzyme Diagnostics OSOM BVBLUE Test |
| K050755 |
Aerobic/Anaerobic Organisms - Vaginal |
Bacteriology |
10/16/2006 |
| HemoCue Hb 301 System |
| K061047 |
Hemoglobin |
Hematology |
10/10/2006 |
| Arkray SPOTCHEM EZ Chemistry Analyzer (Whole Blood) |
| K041427 |
Aspartate Aminotransferase (AST) (SGOT) |
General Chemistry |
10/05/2006 |
| Abaxis Piccolo Point of Care Chemistry Analyzer {Liver Panel Plus Reagent Disc} (Whole Blood) |
| K955770 |
Gamma Glutamyl Transferase (GGT) |
General Chemistry |
10/04/2006 |
| Abaxis Piccolo Point of Care Chemistry Analyzer {Liver Panel Plus Reagent Disc} (Whole Blood) |
| K950164 |
Alanine Aminotransferase (ALT) (SGPT) |
General Chemistry |
10/04/2006 |
| Abaxis Piccolo Point of Care Chemistry Analyzer {Liver Panel Plus Reagent Disc} (Whole Blood) |
| K950164 |
Alkaline Phosphatase (ALP) |
General Chemistry |
10/04/2006 |
| Abaxis Piccolo Point of Care Chemistry Analyzer {Liver Panel Plus Reagent Disc} (Whole Blood) |
| K950164 |
Amylase |
General Chemistry |
10/04/2006 |
| Abaxis Piccolo Point of Care Chemistry Analyzer {Liver Panel Plus Reagent Disc} (Whole Blood) |
| K942782 |
Albumin |
General Chemistry |
10/04/2006 |
| Abaxis Piccolo Point of Care Chemistry Analyzer {Liver Panel Plus Reagent Disc} (Whole Blood) |
| K942782 |
Protein, Total |
General Chemistry |
10/04/2006 |
| Abaxis Piccolo Point of Care Chemistry Analyzer {Liver Panel Plus Reagent Disc} (Whole Blood) |
| K942782 |
Aspartate Aminotransferase (AST) (SGOT) |
General Chemistry |
10/04/2006 |
| Abaxis Piccolo Point of Care Chemistry Analyzer {Liver Panel Plus Reagent Disc} (Whole Blood) |
| K942782 |
Bilirubin, Total |
General Chemistry |
10/04/2006 |
| Arkray SPOTCHEM EZ Chemistry Analyzer (Whole Blood) |
| K050077 |
Urea (BUN) |
General Chemistry |
10/04/2006 |
| Biosite Triage Meterpro (Whole Blood) |
| K021317 |
B-Type Natriuretic Peptide (BNP) |
General Chemistry |
10/04/2006 |
| Card Guard Scientific Survival Ltd. SelfCheck Gluco Diabetes Blood Glucose Test System |
| K061528 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
10/04/2006 |
| Little Nell Labs ThyroChek TSH (Whole Blood) |
| K990658 |
Thyroid Stimulating Hormone (TSH) |
Endocrinology |
10/04/2006 |
| i-Sens Inc. CareSense Blood Glucose Monitoring System |
| K051651 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
10/02/2006 |
| EPS Bio Technology Easy Plus Blood Glucose Monitoring System |
| K061992 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
09/22/2006 |
| OcculTech Fecal Occult Blood Rapid Test |
| K060953 |
Fecal Occult Blood |
General Chemistry |
09/22/2006 |
| ESA Biosciences LeadCare II Blood Lead Testing System (Whole Blood) |
| K052549 |
Blood Lead |
Toxicology / TDM |
09/18/2006 |
| Runbio Biotech Co., Ltd. David Pregnancy Test (Midstream) |
| K053236 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
09/05/2006 |
| Runbio Biotech Co., Ltd. David Pregnancy Test (Strip) |
| K053236 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
09/05/2006 |
| UltraCrit |
| BK050056 |
Hematocrit |
Hematology |
08/31/2006 |
| WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup |
| K050878 |
Amphetamines |
Toxicology / TDM |
08/21/2006 |
| WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup |
| K050878 |
Cannabinoids (THC) |
Toxicology / TDM |
08/21/2006 |
| WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup |
| K050878 |
Phencyclidine (PCP) |
Toxicology / TDM |
08/21/2006 |
| WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup |
| K050878 |
Cocaine Metabolites |
Toxicology / TDM |
08/21/2006 |
| WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup |
| K050878 |
Opiates |
Toxicology / TDM |
08/21/2006 |
| WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup |
| K050878 |
Methamphetamine/Amphetamine |
Toxicology / TDM |
08/21/2006 |
| WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup |
| K050878 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
08/21/2006 |
| ACON Laboratories Inc. Urinalysis Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
08/14/2006 |
| ACON Laboratories Inc. Urinalysis Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
08/14/2006 |
| ACON Laboratories Inc. Urinalysis Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Blood |
Urinalysis |
08/14/2006 |
| ACON Laboratories Inc. Urinalysis Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
08/14/2006 |
| ACON Laboratories Inc. Urinalysis Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
08/14/2006 |
| ACON Laboratories Inc. Urinalysis Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
08/14/2006 |
| ACON Laboratories Inc. Urinalysis Reagent Strips |
| K061559 |
Urine Qualitative Dipstick pH |
Urinalysis |
08/14/2006 |
| ACON Laboratories Inc. Urinalysis Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Protein |
Urinalysis |
08/14/2006 |
| ACON Laboratories Inc. Urinalysis Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
08/14/2006 |
| ACON Laboratories Inc. Urinalysis Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
08/14/2006 |
| ACON Laboratories Inc. Urinalysis Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Ascorbic Acid |
Urinalysis |
08/14/2006 |
| Teco Rapid Fecal Occult Blood (FOB) Card Test |
| K061065 |
Fecal Occult Blood |
General Chemistry |
08/09/2006 |
| Instant Technologies OTC Inc. iTest for Drugs of Abuse, iCassette Home Drug Test for Marijuana (THC) |
| K040327 |
Cannabinoids (THC) |
Toxicology / TDM |
08/08/2006 |
| Instant Technologies OTC Inc. iTest for Drugs of Abuse, iCassette Home Drug Test for Marijuana and Cocaine (THC, COC) |
| K040327 |
Cannabinoids (THC) |
Toxicology / TDM |
08/08/2006 |
| Instant Technologies OTC Inc. iTest for Drugs of Abuse, iCassette Home Drug Test for Marijuana and Cocaine (THC, COC) |
| K040327 |
Cocaine Metabolites |
Toxicology / TDM |
08/08/2006 |
| WayPoint Biomedical Inc. Health Essist Home Drug Test Marijuana and Cocaine |
| K050936 |
Cocaine Metabolites |
Toxicology / TDM |
08/08/2006 |
| Waypoint Biomedical, Inc. Health Essist Home Drug Test Marijuana and Cocaine |
| K050936 |
Cannabinoids (THC) |
Toxicology / TDM |
08/08/2006 |
| Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL |
| K970250 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
08/07/2006 |
| Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL |
| K970250 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
08/07/2006 |
| Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL |
| K970250 |
Urine Qualitative Dipstick Blood |
Urinalysis |
08/07/2006 |
| Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL |
| K970250 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
08/07/2006 |
| Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL |
| K970250 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
08/07/2006 |
| Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL |
| K970250 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
08/07/2006 |
| Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL |
| K970250 |
Urine Qualitative Dipstick pH |
Urinalysis |
08/07/2006 |
| Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL |
| K970250 |
Urine Qualitative Dipstick Protein |
Urinalysis |
08/07/2006 |
| Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL |
| K970250 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
08/07/2006 |
| Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL |
| K970250 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
08/07/2006 |
| ENTERIX INSURE II FECAL IMMUNOCHEMICAL TEST |
| K060930 |
Fecal Occult Blood |
General Chemistry |
08/03/2006 |
| Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips |
| K023885 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
07/27/2006 |
| Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips |
| K023885 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
07/27/2006 |
| Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips |
| K023885 |
Urine Qualitative Dipstick Blood |
Urinalysis |
07/27/2006 |
| Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips |
| K023885 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
07/27/2006 |
| Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips |
| K023885 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
07/27/2006 |
| Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips |
| K023885 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
07/27/2006 |
| Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips |
| K023885 |
Urine Qualitative Dipstick pH |
Urinalysis |
07/27/2006 |
| Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips |
| K023885 |
Urine Qualitative Dipstick Protein |
Urinalysis |
07/27/2006 |
| Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips |
| K023885 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
07/27/2006 |
| Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips |
| K023885 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
07/27/2006 |
| Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips |
| K023885 |
Urine Qualitative Dipstick Ascorbic Acid |
Urinalysis |
07/27/2006 |
| Analyticon Biotechnologies AG Combi-Screen Urine Test Strips |
| K023885 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
07/27/2006 |
| Analyticon Biotechnologies AG Combi-Screen Urine Test Strips |
| K023885 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
07/27/2006 |
| Analyticon Biotechnologies AG Combi-Screen Urine Test Strips |
| K023885 |
Urine Qualitative Dipstick Blood |
Urinalysis |
07/27/2006 |
| Analyticon Biotechnologies AG Combi-Screen Urine Test Strips |
| K023885 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
07/27/2006 |
| Analyticon Biotechnologies AG Combi-Screen Urine Test Strips |
| K023885 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
07/27/2006 |
| Analyticon Biotechnologies AG Combi-Screen Urine Test Strips |
| K023885 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
07/27/2006 |
| Analyticon Biotechnologies AG Combi-Screen Urine Test Strips |
| K023885 |
Urine Qualitative Dipstick pH |
Urinalysis |
07/27/2006 |
| Analyticon Biotechnologies AG Combi-Screen Urine Test Strips |
| K023885 |
Urine Qualitative Dipstick Protein |
Urinalysis |
07/27/2006 |
| Analyticon Biotechnologies AG Combi-Screen Urine Test Strips |
| K023885 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
07/27/2006 |
| Analyticon Biotechnologies AG Combi-Screen Urine Test Strips |
| K023885 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
07/27/2006 |
| Analyticon Biotechnologies AG Combi-Screen Urine Test Strips |
| K023885 |
Urine Qualitative Dipstick Ascorbic Acid |
Urinalysis |
07/27/2006 |
| Diagnostic Devices Prodigy Blood Glucose Test System |
| K060467 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
07/27/2006 |
| Home Diagnostics Element Blood Glucose Monitoring System |
| K060793 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
07/27/2006 |
| PerMaxim RediScreen Mononucleosis (Whole Blood) |
| K042272 |
Infectious Mononucleosis Antibodies (Mono) |
General Immunology |
07/27/2006 |
| IRIS vChem 10 SG Urine Chemistry Stips |
| K861255 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
07/13/2006 |
| IRIS vChem 10 SG Urine Chemistry Strips |
| K861255 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
07/13/2006 |
| IRIS vChem 10 SG Urine Chemistry Strips |
| K861255 |
Urine Qualitative Dipstick Blood |
Urinalysis |
07/13/2006 |
| IRIS vChem 10 SG Urine Chemistry Strips |
| K861255 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
07/13/2006 |
| IRIS vChem 10 SG Urine Chemistry Strips |
| K861255 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
07/13/2006 |
| IRIS vChem 10 SG Urine Chemistry Strips |
| K861255 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
07/13/2006 |
| IRIS vChem 10 SG Urine Chemistry Strips |
| K861255 |
Urine Qualitative Dipstick pH |
Urinalysis |
07/13/2006 |
| IRIS vChem 10 SG Urine Chemistry Strips |
| K861255 |
Urine Qualitative Dipstick Protein |
Urinalysis |
07/13/2006 |
| IRIS vChem 10 SG Urine Chemistry Strips |
| K861255 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
07/13/2006 |
| IRIS vChem 10 SG Urine Chemistry Strips |
| K861255 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
07/13/2006 |
| IRIS vChem 10 SG Urine Chemistry Strips |
| K861255 |
Urine Qualitative Dipstick Ascorbic Acid |
Urinalysis |
07/13/2006 |
| IRIS vChem 2 Urine Chemistry Strips |
| K861255 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
07/13/2006 |
| IRIS vChem 2 Urine Chemistry Strips |
| K861255 |
Urine Qualitative Dipstick Ascorbic Acid |
Urinalysis |
07/13/2006 |
| IRIS vChem 2 Urine Chemstry Strips |
| K861255 |
Urine Qualitative Dipstick Protein |
Urinalysis |
07/13/2006 |
| IRIS vChem 6 Urine Chemistry Strips |
| K861255 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
07/13/2006 |
| IRIS vChem 6 Urine Chemistry Strips |
| K861255 |
Urine Qualitative Dipstick Blood |
Urinalysis |
07/13/2006 |
| IRIS vChem 6 Urine Chemistry Strips |
| K861255 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
07/13/2006 |
| IRIS vChem 6 Urine Chemistry Strips |
| K861255 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
07/13/2006 |
| IRIS vChem 6 Urine Chemistry Strips |
| K861255 |
Urine Qualitative Dipstick pH |
Urinalysis |
07/13/2006 |
| IRIS vChem 6 Urine Chemistry Strips |
| K861255 |
Urine Qualitative Dipstick Protein |
Urinalysis |
07/13/2006 |
| IRIS vChem 6 Urine Chemistry Strips |
| K861255 |
Urine Qualitative Dipstick Ascorbic Acid |
Urinalysis |
07/13/2006 |
| IRIS vChem 8 Urine Chemistry Strips |
| K861255 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
07/13/2006 |
| IRIS vChem 8 Urine Chemistry Strips |
| K861255 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
07/13/2006 |
| IRIS vChem 8 Urine Chemistry Strips |
| K861255 |
Urine Qualitative Dipstick Blood |
Urinalysis |
07/13/2006 |
| IRIS vChem 8 Urine Chemistry Strips |
| K861255 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
07/13/2006 |
| IRIS vChem 8 Urine Chemistry Strips |
| K861255 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
07/13/2006 |
| IRIS vChem 8 Urine Chemistry Strips |
| K861255 |
Urine Qualitative Dipstick pH |
Urinalysis |
07/13/2006 |
| IRIS vChem 8 Urine Chemistry Strips |
| K861255 |
Urine Qualitative Dipstick Protein |
Urinalysis |
07/13/2006 |
| IRIS vChem 8 Urine Chemistry Strips |
| K861255 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
07/13/2006 |
| IRIS vChem 8 Urine Chemistry Strips |
| K861255 |
Urine Qualitative Dipstick Ascorbic Acid |
Urinalysis |
07/13/2006 |
| Diagnostic Devices, Inc. Prodigy Blood Glucose Monitoring System |
| K053593 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
07/07/2006 |
| i-Sense Inc. CareSens Blood Glucose Monitoring System |
| K051651 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
07/07/2006 |
| Beckman Coulter ICON HP test ((for whole blood)) |
| K980798 |
Helicobacter Pylori Antibodies |
General Immunology |
06/30/2006 |
| Beckman Coulter ICON SC Strep A test |
| K040708 |
Streptococcus, Group A |
Bacteriology |
06/30/2006 |
| Gryphus Diagnostics BVBlue |
| K050755 |
Aerobic/Anaerobic Organisms - Vaginal |
Bacteriology |
06/30/2006 |
| PFIZER CONSUMER HEALTHCARE e.p.t. Certainty 1-Step Pregnancy Test |
| K061769 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
06/30/2006 |
| Taidoc Technology easy check TD-4209 Blood Glucose Monitoring System |
| K042005 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/30/2006 |
| Tyson Bioresearch, Inc. EZ-Smart-168 Blood Glucose Monitoring System |
| K052818 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/30/2006 |
| Mizuho USA Multi-Use Electronic Pregnancy Test |
| K060825 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
06/20/2006 |
| Diagnostic Test Group, Clarity Blood Glucose Monitoring System |
| K051854 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/15/2006 |
| HealthPia America Corporation, GlucoPack Blood Glucose Monitoring System |
| K052469 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/15/2006 |
| Immunostics, Inc., hema-screen SPECIFIC Immunochemical Fecal Occult Blood Test |
| K060463 |
Fecal Occult Blood |
General Chemistry |
06/15/2006 |
| Instant Technologies OTC iTest for Drugs Of Abuse, iCassette Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates And Phencyclidine |
| K040629 |
Amphetamines |
Toxicology / TDM |
06/15/2006 |
| Instant Technologies OTC iTest for Drugs Of Abuse, iCassette Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates And Phencyclidine |
| K040629 |
Cannabinoids (THC) |
Toxicology / TDM |
06/15/2006 |
| Instant Technologies OTC iTest for Drugs Of Abuse, iCassette Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates And Phencyclidine |
| K040629 |
Phencyclidine (PCP) |
Toxicology / TDM |
06/15/2006 |
| Instant Technologies OTC iTest for Drugs Of Abuse, iCassette Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates And Phencyclidine |
| K040629 |
Cocaine Metabolites |
Toxicology / TDM |
06/15/2006 |
| Instant Technologies OTC iTest for Drugs Of Abuse, iCassette Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates And Phencyclidine |
| K040629 |
Opiates |
Toxicology / TDM |
06/15/2006 |
| Instant Technologies OTC iTest for Drugs Of Abuse, iCassette Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates And Phencyclidine |
| K040629 |
Methamphetamines |
Toxicology / TDM |
06/15/2006 |
| Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine |
| K041221 |
Amphetamines |
Toxicology / TDM |
06/15/2006 |
| Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine |
| K041221 |
Cannabinoids (THC) |
Toxicology / TDM |
06/15/2006 |
| Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine |
| K041221 |
Phencyclidine (PCP) |
Toxicology / TDM |
06/15/2006 |
| Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine |
| K041221 |
Cocaine Metabolites |
Toxicology / TDM |
06/15/2006 |
| Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine |
| K041221 |
Opiates |
Toxicology / TDM |
06/15/2006 |
| Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine |
| K041221 |
Methamphetamines |
Toxicology / TDM |
06/15/2006 |
| Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine |
| K041221 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
06/15/2006 |
| Taidoc Clever Chek TD-3250 Blood Glucose Plus Blood Pressure Monitoring System |
| K061073 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/06/2006 |
| Inverness Medical, Inc. Clearblue Easy Digital Pregnancy Test |
| K060128 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
06/01/2006 |
| Kareway Product Pure-Aid Pregnancy Test |
| K053452 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
05/31/2006 |
| Meridian Bioscience Immunocard STAT! HpSA (Stool) |
| K032222 |
Helicobacter Pylori |
Bacteriology |
05/31/2006 |
| BTNX Inc. Rapid Response One Step hCG Pregnancy Urine Test Cassette |
| K050305 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
05/22/2006 |
| BTNX Inc. Rapid Response One Step hCG Pregnancy Urine Test Strip |
| K050305 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
05/22/2006 |
| BTNX Inc. Rapid Response One Step hCG Pregnancy Urine/Serum Combo Cassette Test |
| K050305 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
05/22/2006 |
| Jant Pharmacal Accutest URS 10 Urine Reagent Strips |
| K993850 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
05/22/2006 |
| Jant Pharmacal Accutest URS 10 Urine Reagent Strips |
| K993850 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
05/22/2006 |
| Jant Pharmacal Accutest URS 10 Urine Reagent Strips |
| K993850 |
Urine Qualitative Dipstick Blood |
Urinalysis |
05/22/2006 |
| Jant Pharmacal Accutest URS 10 Urine Reagent Strips |
| K993850 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
05/22/2006 |
| Jant Pharmacal Accutest URS 10 Urine Reagent Strips |
| K993850 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
05/22/2006 |
| Jant Pharmacal Accutest URS 10 Urine Reagent Strips |
| K993850 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
05/22/2006 |
| Jant Pharmacal Accutest URS 10 Urine Reagent Strips |
| K993850 |
Urine Qualitative Dipstick pH |
Urinalysis |
05/22/2006 |
| Jant Pharmacal Accutest URS 10 Urine Reagent Strips |
| K993850 |
Urine Qualitative Dipstick Protein |
Urinalysis |
05/22/2006 |
| Jant Pharmacal Accutest URS 10 Urine Reagent Strips |
| K993850 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
05/22/2006 |
| Jant Pharmacal Accutest URS 10 Urine Reagent Strips |
| K993850 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
05/22/2006 |
| Jant Pharmacal Accutest URS 2 Urine Reagent Strips |
| K993850 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
05/22/2006 |
| Jant Pharmacal Accutest URS 2 Urine Reagent Strips |
| K993850 |
Urine Qualitative Dipstick Protein |
Urinalysis |
05/22/2006 |
| Jant Pharmacal Accutest URS 4 Urine Reagent Strips |
| K993850 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
05/22/2006 |
| Jant Pharmacal Accutest URS 4 Urine Reagent Strips |
| K993850 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
05/22/2006 |
| Jant Pharmacal Accutest URS 4 Urine Reagent Strips |
| K993850 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
05/22/2006 |
| Jant Pharmacal Accutest URS 4 Urine Reagent Strips |
| K993850 |
Urine Qualitative Dipstick Protein |
Urinalysis |
05/22/2006 |
| LifeScan OneTouch UltraMini Blood Glucose Monitoring System |
| K061118 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
05/22/2006 |
| Progressive Health Supply and Source Smartest Protege Blood Glucose Monitoring System |
| K032029 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
05/22/2006 |
| CEN-MED Elite Plus hCG One Step Pregnancy Test Device (Urine/Serum) |
| K981165 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
05/15/2006 |
| Abbott Diabetes Care Inc. Optium Blood Glucose Monitoring System |
| K033845 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
05/01/2006 |
| Acon Laboratories Multi-Clin Drug Screen Test Device |
| K041685 |
Amphetamines |
Toxicology / TDM |
05/01/2006 |
| Acon Laboratories Multi-Clin Drug Screen Test Device |
| K041685 |
Cannabinoids (THC) |
Toxicology / TDM |
05/01/2006 |
| Acon Laboratories Multi-Clin Drug Screen Test Device |
| K041685 |
Phencyclidine (PCP) |
Toxicology / TDM |
05/01/2006 |
| Acon Laboratories Multi-Clin Drug Screen Test Device |
| K041685 |
Cocaine Metabolites |
Toxicology / TDM |
05/01/2006 |
| Acon Laboratories Multi-Clin Drug Screen Test Device |
| K041685 |
Propoxyphene |
Toxicology / TDM |
05/01/2006 |
| Acon Laboratories Multi-Clin Drug Screen Test Device |
| K041685 |
Benzodiazepines |
Toxicology / TDM |
05/01/2006 |
| Acon Laboratories Multi-Clin Drug Screen Test Device |
| K041685 |
Barbiturates |
Toxicology / TDM |
05/01/2006 |
| Acon Laboratories Multi-Clin Drug Screen Test Device |
| K041685 |
Morphine |
Toxicology / TDM |
05/01/2006 |
| Acon Laboratories Multi-Clin Drug Screen Test Device |
| K041685 |
Tricyclic Antidepressants |
Toxicology / TDM |
05/01/2006 |
| Acon Laboratories Multi-Clin Drug Screen Test Device |
| K041685 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
05/01/2006 |
| Acon Laboratories Multi-Clin Drug Screen Test Device |
| K041685 |
Oxycodone |
Toxicology / TDM |
05/01/2006 |
| Acon Laboratories Tri-Fect Drug Screen Test Device |
| K041743 |
Amphetamines |
Toxicology / TDM |
05/01/2006 |
| Acon Laboratories Tri-Fect Drug Screen Test Device |
| K041743 |
Cannabinoids (THC) |
Toxicology / TDM |
05/01/2006 |
| Acon Laboratories Tri-Fect Drug Screen Test Device |
| K041743 |
Phencyclidine (PCP) |
Toxicology / TDM |
05/01/2006 |
| Acon Laboratories Tri-Fect Drug Screen Test Device |
| K041743 |
Cocaine Metabolites |
Toxicology / TDM |
05/01/2006 |
| Acon Laboratories Tri-Fect Drug Screen Test Device |
| K041743 |
Propoxyphene |
Toxicology / TDM |
05/01/2006 |
| Acon Laboratories Tri-Fect Drug Screen Test Device |
| K041743 |
Benzodiazepines |
Toxicology / TDM |
05/01/2006 |
| Acon Laboratories Tri-Fect Drug Screen Test Device |
| K041743 |
Barbiturates |
Toxicology / TDM |
05/01/2006 |
| Acon Laboratories Tri-Fect Drug Screen Test Device |
| K041743 |
Morphine |
Toxicology / TDM |
05/01/2006 |
| Acon Laboratories Tri-Fect Drug Screen Test Device |
| K041743 |
Tricyclic Antidepressants |
Toxicology / TDM |
05/01/2006 |
| Acon Laboratories Tri-Fect Drug Screen Test Device |
| K041743 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
05/01/2006 |
| Acon Laboratories Tri-Fect Drug Screen Test Device |
| K041743 |
Oxycodone |
Toxicology / TDM |
05/01/2006 |
| First Check Diagnostics LLC, First Check Home Drug Test Marijuana |
| K050936 |
Cannabinoids (THC) |
Toxicology / TDM |
05/01/2006 |
| Solartek Products, Inc. Kroger Blood Glucose Monitoring System |
| K033845 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
05/01/2006 |
| Solartek Products, Inc. ReliOn Ultima Blood Glucose Monitoring System |
| K033845 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
05/01/2006 |
| Solartek Products, Inc. RiteAid Blood Glucose Monitoring System |
| K033845 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
05/01/2006 |
| BinaxNOW Influenza A & B Test (Nasopharyngeal (Np) Swab And Nasal Wash/Aspirate Specimens) |
| K053126 |
Influenza A/B |
Virology |
04/19/2006 |
| MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters) |
| K993850 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
04/19/2006 |
| MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters) |
| K993850 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
04/19/2006 |
| MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters) |
| K993850 |
Urine Qualitative Dipstick Blood |
Urinalysis |
04/19/2006 |
| MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters) |
| K993850 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
04/19/2006 |
| MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters) |
| K993850 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
04/19/2006 |
| MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters) |
| K993850 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
04/19/2006 |
| MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters) |
| K993850 |
Urine Qualitative Dipstick pH |
Urinalysis |
04/19/2006 |
| MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters) |
| K993850 |
Urine Qualitative Dipstick Protein |
Urinalysis |
04/19/2006 |
| MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters) |
| K993850 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
04/19/2006 |
| MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters) |
| K993850 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
04/19/2006 |
| Noble Medical Inc. Split-Specimen Cup |
| K050878 |
Amphetamines |
Toxicology / TDM |
04/19/2006 |
| Noble Medical Inc. Split-Specimen Cup |
| K050878 |
Cannabinoids (THC) |
Toxicology / TDM |
04/19/2006 |
| Noble Medical Inc. Split-Specimen Cup |
| K050878 |
Phencyclidine (PCP) |
Toxicology / TDM |
04/19/2006 |
| Noble Medical Inc. Split-Specimen Cup |
| K050878 |
Cocaine Metabolites |
Toxicology / TDM |
04/19/2006 |
| Noble Medical Inc. Split-Specimen Cup |
| K050878 |
Opiates |
Toxicology / TDM |
04/19/2006 |
| Noble Medical Inc. Split-Specimen Cup |
| K050878 |
Methamphetamines |
Toxicology / TDM |
04/19/2006 |
| Noble Medical Inc. Split-Specimen Cup |
| K050878 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
04/19/2006 |
| US Diagnostics, Inc. G4 Blood Glucose Monitoring System |
| K051651 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
04/19/2006 |
| DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis |
| K052525 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
04/11/2006 |
| DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis |
| K052525 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
04/11/2006 |
| DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis |
| K052525 |
Urine Qualitative Dipstick Blood |
Urinalysis |
04/11/2006 |
| DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis |
| K052525 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
04/11/2006 |
| DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis |
| K052525 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
04/11/2006 |
| DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis |
| K052525 |
Urine Qualitative Dipstick pH |
Urinalysis |
04/11/2006 |
| DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis |
| K052525 |
Urine Qualitative Dipstick Protein |
Urinalysis |
04/11/2006 |
| DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis |
| K052525 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
04/11/2006 |
| DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis |
| K052525 |
Urine Qualitative Dipstick Ascorbic Acid |
Urinalysis |
04/11/2006 |
| DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis |
| K052525 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
04/11/2006 |
| DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis |
| K052525 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
04/11/2006 |
| Polymer Technology Systems CardioChek Analyzer {PTS PANELS HDL Cholesterol Test Strips} |
| K060617 |
HDL Cholesterol |
General Chemistry |
04/10/2006 |
| Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS HDL Cholesterol Test Strips} |
| K060617 |
HDL Cholesterol |
General Chemistry |
04/10/2006 |
| Hypoguard Assure Pro Blood Glucose Monitoring System |
| K053079 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/30/2006 |
| Rapid Pathogen Screening RPS Adeno Detector |
| K052092 |
Adenovirus |
Virology |
03/30/2006 |
| immoCARE Fecal Occult Blood Test |
| K052598 |
Fecal Occult Blood |
General Chemistry |
03/22/2006 |
| Abbott Freestyle Feedom Blood Glucose Monitoring System |
| K051839 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/13/2006 |
| Johnson & Johnson, Lifescan, Inc. One Touch Basic Blood Glucose Meter {Incline Medical, LLC Accurex Glucose Test Strip} |
| K052207 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/13/2006 |
| Johnson & Johnson, Lifescan, Inc. One Touch II Blood Glucose Meter {Incline Medical, LLC Accurex Glucose Test Strip} |
| K052207 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/13/2006 |
| Johnson & Johnson, Lifescan, Inc. One Touch Profile Blood Glucose Meter {Incline Medical, LLC Accurex Glucose Test Strip} |
| K052207 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/13/2006 |
| MACHEREY-NAGEL Medi-Test Combi 10 SGL |
| K991927 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
03/13/2006 |
| MACHEREY-NAGEL Medi-Test Combi 10 SGL |
| K991927 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
03/13/2006 |
| MACHEREY-NAGEL Medi-Test Combi 10 SGL |
| K991927 |
Urine Qualitative Dipstick Blood |
Urinalysis |
03/13/2006 |
| MACHEREY-NAGEL Medi-Test Combi 10 SGL |
| K991927 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
03/13/2006 |
| MACHEREY-NAGEL Medi-Test Combi 10 SGL |
| K991927 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
03/13/2006 |
| MACHEREY-NAGEL Medi-Test Combi 10 SGL |
| K991927 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
03/13/2006 |
| MACHEREY-NAGEL Medi-Test Combi 10 SGL |
| K991927 |
Urine Qualitative Dipstick pH |
Urinalysis |
03/13/2006 |
| MACHEREY-NAGEL Medi-Test Combi 10 SGL |
| K991927 |
Urine Qualitative Dipstick Protein |
Urinalysis |
03/13/2006 |
| MACHEREY-NAGEL Medi-Test Combi 10 SGL |
| K991927 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
03/13/2006 |
| MACHEREY-NAGEL Medi-Test Combi 10 SGL |
| K991927 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
03/13/2006 |
| Bioptik Technology, Inc. EasyMate Blood Glucose Monitoring System |
| K053312 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/09/2006 |
| Ani Biotech Oy MySet Pregnancy Test |
| K053138 |
hCG, Urine |
Endocrinology |
03/03/2006 |
| Biotechnostix, Inc. Rapid Response One Step Multi-Drug, Multi-Line Screen Test Device |
| K050050 |
Amphetamines |
Toxicology / TDM |
03/03/2006 |
| Biotechnostix, Inc. Rapid Response One Step Multi-Drug, Multi-Line Screen Test Device |
| K050050 |
Cannabinoids (THC) |
Toxicology / TDM |
03/03/2006 |
| Biotechnostix, Inc. Rapid Response One Step Multi-Drug, Multi-Line Screen Test Device |
| K050050 |
Phencyclidine (PCP) |
Toxicology / TDM |
03/03/2006 |
| Biotechnostix, Inc. Rapid Response One Step Multi-Drug, Multi-Line Screen Test Device |
| K050050 |
Cocaine Metabolites |
Toxicology / TDM |
03/03/2006 |
| Biotechnostix, Inc. Rapid Response One Step Multi-Drug, Multi-Line Screen Test Device |
| K050050 |
Opiates |
Toxicology / TDM |
03/03/2006 |
| Biotechnostix, Inc. Rapid Response One Step Multi-Drug, Multi-Line Screen Test Device |
| K050050 |
Methamphetamines |
Toxicology / TDM |
03/03/2006 |
| Biotechnostix Rapid Response Multi-Drug, Multi-Line Screen Test Card with Integrated Cup |
| K050878 |
Amphetamines |
Toxicology / TDM |
02/27/2006 |
| Biotechnostix Rapid Response Multi-Drug, Multi-Line Screen Test Card with Integrated Cup |
| K050878 |
Cannabinoids (THC) |
Toxicology / TDM |
02/27/2006 |
| Biotechnostix Rapid Response Multi-Drug, Multi-Line Screen Test Card with Integrated Cup |
| K050878 |
Phencyclidine (PCP) |
Toxicology / TDM |
02/27/2006 |
| Biotechnostix Rapid Response Multi-Drug, Multi-Line Screen Test Card with Integrated Cup |
| K050878 |
Cocaine Metabolites |
Toxicology / TDM |
02/27/2006 |
| Biotechnostix Rapid Response Multi-Drug, Multi-Line Screen Test Card with Integrated Cup |
| K050878 |
Opiates |
Toxicology / TDM |
02/27/2006 |
| Biotechnostix Rapid Response Multi-Drug, Multi-Line Screen Test Card with Integrated Cup |
| K050878 |
Methamphetamines |
Toxicology / TDM |
02/27/2006 |
| Biotechnostix Rapid Response Multi-Drug, Multi-Line Screen Test Card with Integrated Cup |
| K050878 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
02/27/2006 |
| Artron One-Step Human Chorionic Gonadotropin (hCG) Pregnancy Test Cassette |
| K060019 |
hCG, Urine |
Endocrinology |
02/22/2006 |
| Artron One-Step Human Chorionic Gonadotropin (hCG) Pregnancy Test Midstream |
| K060019 |
hCG, Urine |
Endocrinology |
02/22/2006 |
| Artron One-Step Human Chorionic Gonadotropin (hCG) Pregnancy Test Strip |
| K060019 |
hCG, Urine |
Endocrinology |
02/22/2006 |
| Artron One-Step Pregnancy Test |
| K060019 |
hCG, Urine |
Endocrinology |
02/22/2006 |
| Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips |
| K993850 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
02/22/2006 |
| Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips |
| K993850 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
02/22/2006 |
| Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips |
| K993850 |
Urine Qualitative Dipstick Blood |
Urinalysis |
02/22/2006 |
| Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips |
| K993850 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
02/22/2006 |
| Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips |
| K993850 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
02/22/2006 |
| Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips |
| K993850 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
02/22/2006 |
| Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips |
| K993850 |
Urine Qualitative Dipstick pH |
Urinalysis |
02/22/2006 |
| Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips |
| K993850 |
Urine Qualitative Dipstick Protein |
Urinalysis |
02/22/2006 |
| Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips |
| K993850 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
02/22/2006 |
| Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips |
| K993850 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
02/22/2006 |
| First Check Diagnostics First Check 12 Drug Test |
| K052115 |
Amphetamines |
Toxicology / TDM |
02/22/2006 |
| First Check Diagnostics First Check 12 Drug Test |
| K052115 |
Cannabinoids (THC) |
Toxicology / TDM |
02/22/2006 |
| First Check Diagnostics First Check 12 Drug Test |
| K052115 |
Phencyclidine (PCP) |
Toxicology / TDM |
02/22/2006 |
| First Check Diagnostics First Check 12 Drug Test |
| K052115 |
Cocaine Metabolites |
Toxicology / TDM |
02/22/2006 |
| First Check Diagnostics First Check 12 Drug Test |
| K052115 |
Opiates |
Toxicology / TDM |
02/22/2006 |
| First Check Diagnostics First Check 12 Drug Test |
| K052115 |
Methadone |
Toxicology / TDM |
02/22/2006 |
| First Check Diagnostics First Check 12 Drug Test |
| K052115 |
Methamphetamines |
Toxicology / TDM |
02/22/2006 |
| First Check Diagnostics First Check 12 Drug Test |
| K052115 |
Benzodiazepines |
Toxicology / TDM |
02/22/2006 |
| First Check Diagnostics First Check 12 Drug Test |
| K052115 |
Barbiturates |
Toxicology / TDM |
02/22/2006 |
| First Check Diagnostics First Check 12 Drug Test |
| K052115 |
Tricyclic Antidepressants |
Toxicology / TDM |
02/22/2006 |
| First Check Diagnostics First Check 12 Drug Test |
| K052115 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
02/22/2006 |
| First Check Diagnostics First Check 12 Drug Test |
| K052115 |
Oxycodone |
Toxicology / TDM |
02/22/2006 |
| Genzyme Sure-Vue Signature MONO Test (Whole Blood) |
| K972231 |
Infectious Mononucleosis Antibodies (Mono) |
General Immunology |
02/22/2006 |
| Germaine Laboratories AimStick 10-SG |
| K051727 |
Urine Qualitative Dipstick Chemistries |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-2 |
| K051727 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-2 |
| K051727 |
Urine Qualitative Dipstick Protein |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-2GK |
| K051727 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-2GK |
| K051727 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-2GpH |
| K051727 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-2GpH |
| K051727 |
Urine Qualitative Dipstick pH |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-2LN |
| K051727 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-2LN |
| K051727 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-3 |
| K051727 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-3 |
| K051727 |
Urine Qualitative Dipstick pH |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-3 |
| K051727 |
Urine Qualitative Dipstick Protein |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-4 |
| K051727 |
Urine Qualitative Dipstick Blood |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-4 |
| K051727 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-4 |
| K051727 |
Urine Qualitative Dipstick pH |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-4 |
| K051727 |
Urine Qualitative Dipstick Protein |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-4OB |
| K051727 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-4OB |
| K051727 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-4OB |
| K051727 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-4OB |
| K051727 |
Urine Qualitative Dipstick Protein |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-5 |
| K051727 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-5 |
| K051727 |
Urine Qualitative Dipstick Blood |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-5 |
| K051727 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-5 |
| K051727 |
Urine Qualitative Dipstick pH |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-5 |
| K051727 |
Urine Qualitative Dipstick Protein |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-6 |
| K051727 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-6 |
| K051727 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-6 |
| K051727 |
Urine Qualitative Dipstick Blood |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-6 |
| K051727 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-6 |
| K051727 |
Urine Qualitative Dipstick pH |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-6 |
| K051727 |
Urine Qualitative Dipstick Protein |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-7 |
| K051727 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-7 |
| K051727 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-7 |
| K051727 |
Urine Qualitative Dipstick Blood |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-7 |
| K051727 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-7 |
| K051727 |
Urine Qualitative Dipstick pH |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-7 |
| K051727 |
Urine Qualitative Dipstick Protein |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-7 |
| K051727 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-8 |
| K051727 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-8 |
| K051727 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-8 |
| K051727 |
Urine Qualitative Dipstick Blood |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-8 |
| K051727 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-8 |
| K051727 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-8 |
| K051727 |
Urine Qualitative Dipstick pH |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-8 |
| K051727 |
Urine Qualitative Dipstick Protein |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-8 |
| K051727 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-9 |
| K051727 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-9 |
| K051727 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-9 |
| K051727 |
Urine Qualitative Dipstick Blood |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-9 |
| K051727 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-9 |
| K051727 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-9 |
| K051727 |
Urine Qualitative Dipstick pH |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-9 |
| K051727 |
Urine Qualitative Dipstick Protein |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-9 |
| K051727 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-9 |
| K051727 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-B |
| K051727 |
Urine Qualitative Dipstick Blood |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-BR |
| K051727 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-G |
| K051727 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-K |
| K051727 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-L |
| K051727 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-N |
| K051727 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-P |
| K051727 |
Urine Qualitative Dipstick Protein |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-pH |
| K051727 |
Urine Qualitative Dipstick pH |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-SG |
| K051727 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
02/22/2006 |
| Germaine Laboratories AimStick US-U |
| K051727 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
02/22/2006 |
| ImmuLab, Inc. One Step Pregnancy Test Strip (Urine) |
| K993203 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
02/22/2006 |
| Instant Technologies Inc. One Step LH Ovulation Test Cassette |
| X050002 |
Ovulation Test (LH) By Visual Color Comparison |
Endocrinology |
02/22/2006 |
| Instant Technologies Inc. One Step LH Ovulation Test Strip |
| X050002 |
Ovulation Test (LH) By Visual Color Comparison |
Endocrinology |
02/22/2006 |
| Lifescan One Touch Ultra 2 Blood Glucose Monitoring System |
| K053529 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
02/22/2006 |
| RAC Medical Clarity MONO Mononucleosis Rapid Test Device (Whole Blood) |
| K042272 |
Infectious Mononucleosis Antibodies (Mono) |
General Immunology |
02/22/2006 |
| Saless Enterprises Inc. One Step LH Ovulation Test Cassette |
| X050002 |
Ovulation Test (LH) By Visual Color Comparison |
Endocrinology |
02/22/2006 |
| Axis-Shield Afinion AS100 Analyzer |
| K050574 |
Glycosylated Hemoglobin (Hgb A1c) |
General Chemistry |
02/17/2006 |
| Albertsons Equaline Sidekick Blood Glucose Testing System |
| K051147 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
02/09/2006 |
| Chain Drug Consortium Premier Value Sidekick Blood Glucose Testing System |
| K051147 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
02/09/2006 |
| CTMI URINALYSIS REAGENT STRIPS (1-4 PARAMETERS) GLUCOSE/ PROTEIN/ NITRITE/ LEUKOCYTE/ KETONE/ PH/ BLOOD |
| K993850 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
02/09/2006 |
| CTMI URINALYSIS REAGENT STRIPS (1-4 PARAMETERS) GLUCOSE/ PROTEIN/ NITRITE/ LEUKOCYTE/ KETONE/ PH/ BLOOD |
| K993850 |
Urine Qualitative Dipstick Blood |
Urinalysis |
02/09/2006 |
| CTMI URINALYSIS REAGENT STRIPS (1-4 PARAMETERS) GLUCOSE/ PROTEIN/ NITRITE/ LEUKOCYTE/ KETONE/ PH/ BLOOD |
| K993850 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
02/09/2006 |
| CTMI URINALYSIS REAGENT STRIPS (1-4 PARAMETERS) GLUCOSE/ PROTEIN/ NITRITE/ LEUKOCYTE/ KETONE/ PH/ BLOOD |
| K993850 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
02/09/2006 |
| CTMI URINALYSIS REAGENT STRIPS (1-4 PARAMETERS) GLUCOSE/ PROTEIN/ NITRITE/ LEUKOCYTE/ KETONE/ PH/ BLOOD |
| K993850 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
02/09/2006 |
| CTMI URINALYSIS REAGENT STRIPS (1-4 PARAMETERS) GLUCOSE/ PROTEIN/ NITRITE/ LEUKOCYTE/ KETONE/ PH/ BLOOD |
| K993850 |
Urine Qualitative Dipstick pH |
Urinalysis |
02/09/2006 |
| CTMI URINALYSIS REAGENT STRIPS (1-4 PARAMETERS) GLUCOSE/ PROTEIN/ NITRITE/ LEUKOCYTE/ KETONE/ PH/ BLOOD |
| K993850 |
Urine Qualitative Dipstick Protein |
Urinalysis |
02/09/2006 |
| CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES |
| K993850 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
02/09/2006 |
| CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES |
| K993850 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
02/09/2006 |
| CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES |
| K993850 |
Urine Qualitative Dipstick Blood |
Urinalysis |
02/09/2006 |
| CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES |
| K993850 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
02/09/2006 |
| CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES |
| K993850 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
02/09/2006 |
| CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES |
| K993850 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
02/09/2006 |
| CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES |
| K993850 |
Urine Qualitative Dipstick pH |
Urinalysis |
02/09/2006 |
| CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES |
| K993850 |
Urine Qualitative Dipstick Protein |
Urinalysis |
02/09/2006 |
| CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES |
| K993850 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
02/09/2006 |
| CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES |
| K993850 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
02/09/2006 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-6 Parameters Glucose/Protein/pH/Blood/Ketone/Bilirubin |
| K993850 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
02/09/2006 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-6 Parameters Glucose/Protein/pH/Blood/Ketone/Bilirubin |
| K993850 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
02/09/2006 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-6 Parameters Glucose/Protein/pH/Blood/Ketone/Bilirubin |
| K993850 |
Urine Qualitative Dipstick Blood |
Urinalysis |
02/09/2006 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-6 Parameters Glucose/Protein/pH/Blood/Ketone/Bilirubin |
| K993850 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
02/09/2006 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-6 Parameters Glucose/Protein/pH/Blood/Ketone/Bilirubin |
| K993850 |
Urine Qualitative Dipstick pH |
Urinalysis |
02/09/2006 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-6 Parameters Glucose/Protein/pH/Blood/Ketone/Bilirubin |
| K993850 |
Urine Qualitative Dipstick Protein |
Urinalysis |
02/09/2006 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-7 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite |
| K993850 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
02/09/2006 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-7 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite |
| K993850 |
Urine Qualitative Dipstick Blood |
Urinalysis |
02/09/2006 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-7 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite |
| K993850 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
02/09/2006 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-7 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite |
| K993850 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
02/09/2006 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-7 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite |
| K993850 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
02/09/2006 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-7 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite |
| K993850 |
Urine Qualitative Dipstick pH |
Urinalysis |
02/09/2006 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-7 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite |
| K993850 |
Urine Qualitative Dipstick Protein |
Urinalysis |
02/09/2006 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity |
| K993850 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
02/09/2006 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity |
| K993850 |
Urine Qualitative Dipstick Blood |
Urinalysis |
02/09/2006 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity |
| K993850 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
02/09/2006 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity |
| K993850 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
02/09/2006 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity |
| K993850 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
02/09/2006 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity |
| K993850 |
Urine Qualitative Dipstick pH |
Urinalysis |
02/09/2006 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity |
| K993850 |
Urine Qualitative Dipstick Protein |
Urinalysis |
02/09/2006 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity |
| K993850 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
02/09/2006 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen |
| K993850 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
02/09/2006 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen |
| K993850 |
Urine Qualitative Dipstick Blood |
Urinalysis |
02/09/2006 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen |
| K993850 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
02/09/2006 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen |
| K993850 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
02/09/2006 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen |
| K993850 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
02/09/2006 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen |
| K993850 |
Urine Qualitative Dipstick pH |
Urinalysis |
02/09/2006 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen |
| K993850 |
Urine Qualitative Dipstick Protein |
Urinalysis |
02/09/2006 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen |
| K993850 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
02/09/2006 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen |
| K993850 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
02/09/2006 |
| McKesson SunMark Sidekick Blood Glucose Testing System |
| K051147 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
02/09/2006 |
| Safeway Sidekick Blood Glucose Testing System |
| K051147 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
02/09/2006 |
| AgaMatrix Liberty Blood Glucose Monitoring System |
| K052762 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
01/24/2006 |
| AgaMatrix Liberty Blood Glucose Monitoring System {Professional Use} |
| K052762 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
01/24/2006 |
| DE Healthcare Products Ultrascreen 10+SG |
| K991927 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
01/24/2006 |
| DE Healthcare Products Ultrascreen 10+SG |
| K991927 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
01/24/2006 |
| DE Healthcare Products Ultrascreen 10+SG |
| K991927 |
Urine Qualitative Dipstick Blood |
Urinalysis |
01/24/2006 |
| DE Healthcare Products Ultrascreen 10+SG |
| K991927 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
01/24/2006 |
| DE Healthcare Products Ultrascreen 10+SG |
| K991927 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
01/24/2006 |
| DE Healthcare Products Ultrascreen 10+SG |
| K991927 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
01/24/2006 |
| DE Healthcare Products Ultrascreen 10+SG |
| K991927 |
Urine Qualitative Dipstick pH |
Urinalysis |
01/24/2006 |
| DE Healthcare Products Ultrascreen 10+SG |
| K991927 |
Urine Qualitative Dipstick Protein |
Urinalysis |
01/24/2006 |
| DE Healthcare Products Ultrascreen 10+SG |
| K991927 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
01/24/2006 |
| DE Healthcare Products Ultrascreen 10+SG |
| K991927 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
01/24/2006 |
| DE Healthcare Products Ultrascreen 10+SG |
| K991927 |
Urine Qualitative Dipstick Ascorbic Acid |
Urinalysis |
01/24/2006 |
| First Check Diagnostics First Check Multi Drug Cup |
| K051966 |
Amphetamines |
Toxicology / TDM |
01/17/2006 |
| First Check Diagnostics First Check Multi Drug Cup |
| K051966 |
Cannabinoids (THC) |
Toxicology / TDM |
01/17/2006 |
| First Check Diagnostics First Check Multi Drug Cup |
| K051966 |
Phencyclidine (PCP) |
Toxicology / TDM |
01/17/2006 |
| First Check Diagnostics First Check Multi Drug Cup |
| K051966 |
Cocaine Metabolites |
Toxicology / TDM |
01/17/2006 |
| First Check Diagnostics First Check Multi Drug Cup |
| K051966 |
Opiates |
Toxicology / TDM |
01/17/2006 |
| First Check Diagnostics First Check Multi Drug Cup |
| K051966 |
Methamphetamines |
Toxicology / TDM |
01/17/2006 |
| First Check Diagnostics First Check Multi Drug Cup |
| K051966 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
01/17/2006 |
| Biotechnostix, Inc. Rapid Response FSH One Step Menopause Test Device (Professional Use) |
| K041165 |
Follicle Stimulating Hormone (FSH) |
Endocrinology |
01/10/2006 |
| First Check Multi Drug Cup 12 (OTC) |
| K052115 |
Amphetamines |
Toxicology / TDM |
01/10/2006 |
| First Check Multi Drug Cup 12 (OTC) |
| K052115 |
Cannabinoids (THC) |
Toxicology / TDM |
01/10/2006 |
| First Check Multi Drug Cup 12 (OTC) |
| K052115 |
Phencyclidine (PCP) |
Toxicology / TDM |
01/10/2006 |
| First Check Multi Drug Cup 12 (OTC) |
| K052115 |
Cocaine Metabolites |
Toxicology / TDM |
01/10/2006 |
| First Check Multi Drug Cup 12 (OTC) |
| K052115 |
Opiates |
Toxicology / TDM |
01/10/2006 |
| First Check Multi Drug Cup 12 (OTC) |
| K052115 |
Methadone |
Toxicology / TDM |
01/10/2006 |
| First Check Multi Drug Cup 12 (OTC) |
| K052115 |
Methamphetamines |
Toxicology / TDM |
01/10/2006 |
| First Check Multi Drug Cup 12 (OTC) |
| K052115 |
Benzodiazepines |
Toxicology / TDM |
01/10/2006 |
| First Check Multi Drug Cup 12 (OTC) |
| K052115 |
Barbiturates |
Toxicology / TDM |
01/10/2006 |
| First Check Multi Drug Cup 12 (OTC) |
| K052115 |
Tricyclic Antidepressants |
Toxicology / TDM |
01/10/2006 |
| First Check Multi Drug Cup 12 (OTC) |
| K052115 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
01/10/2006 |
| First Check Multi Drug Cup 12 (OTC) |
| K052115 |
Oxycodone |
Toxicology / TDM |
01/10/2006 |
| RAC Medical Clarity FSH One Step Menopause Test Device (Professional Use) |
| K041165 |
Follicle Stimulating Hormone (FSH) |
Endocrinology |
01/10/2006 |
| IND Diagnostic Inc. One Step HCG Pregnancy Test 2000 mIU/mL |
| K052694 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
12/19/2005 |
| Rapid Response Mononucleosis Rapid Test Device (whole blood) |
| K042272 |
Infectious Mononucleosis Antibodies (Mono) |
General Immunology |
12/15/2005 |
| Aventir Biotech, LLC Glucose Pilot Monitoring System |
| K052208 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
12/12/2005 |
| Sein Electronics Blood Glucose and Blood Pressure Measurement System, Model BGP-100 |
| K052108 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
12/08/2005 |
| Runbio Biotech Co., Ltd. David Ovulation Test |
| K053239 |
Ovulation Test (LH) By Visual Color Comparison |
Endocrinology |
12/07/2005 |
| Runbio Biotech Co., Ltd. David Ovulation Test |
| K053238 |
Ovulation Test (LH) By Visual Color Comparison |
Endocrinology |
12/06/2005 |
| IND Diagnostic INC. One Step FSH Menopausal Test (Cassette) |
| K052662 |
Follicle Stimulating Hormone (FSH) |
Endocrinology |
12/02/2005 |
| IND Diagnostic INC. One Step FSH Menopausal Test (midstream) |
| K052662 |
Follicle Stimulating Hormone (FSH) |
Endocrinology |
12/02/2005 |
| IND Diagnostic INC. One Step FSH Menopausal Test (Strip) |
| K052662 |
Follicle Stimulating Hormone (FSH) |
Endocrinology |
12/02/2005 |
| IND Diagnostic, Inc. One Step Cassette Style FSH Menopausal Test (Professional Use) |
| K052662 |
Follicle Stimulating Hormone (FSH) |
Endocrinology |
12/02/2005 |
| IND Diagnostic, Inc. One Step Strip Style FSH Menopausal Test (Professional Use) |
| K052662 |
Follicle Stimulating Hormone (FSH) |
Endocrinology |
12/02/2005 |
| Target Corporation EasyPRO Blood Glucose Mornitoring System |
| K031388 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
12/02/2005 |
| BioJENC Uro-nDip UTI Urinalysis Reagent Strip |
| X050011 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
11/29/2005 |
| BioJENC Uro-nDip UTI Urinalysis Reagent Strip |
| X050011 |
Urine Qualitative Dipstick pH |
Urinalysis |
11/29/2005 |
| Henry Schein Urispec 11-Way Reagent Strip |
| K991927 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
11/29/2005 |
| Henry Schein Urispec 11-Way Reagent Strip |
| K991927 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
11/29/2005 |
| Henry Schein Urispec 11-Way Reagent Strip |
| K991927 |
Urine Qualitative Dipstick Blood |
Urinalysis |
11/29/2005 |
| Henry Schein Urispec 11-Way Reagent Strip |
| K991927 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
11/29/2005 |
| Henry Schein Urispec 11-Way Reagent Strip |
| K991927 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
11/29/2005 |
| Henry Schein Urispec 11-Way Reagent Strip |
| K991927 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
11/29/2005 |
| Henry Schein Urispec 11-Way Reagent Strip |
| K991927 |
Urine Qualitative Dipstick pH |
Urinalysis |
11/29/2005 |
| Henry Schein Urispec 11-Way Reagent Strip |
| K991927 |
Urine Qualitative Dipstick Protein |
Urinalysis |
11/29/2005 |
| Henry Schein Urispec 11-Way Reagent Strip |
| K991927 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
11/29/2005 |
| Henry Schein Urispec 11-Way Reagent Strip |
| K991927 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
11/29/2005 |
| Henry Schein Urispec 11-Way Reagent Strip |
| K991927 |
Urine Qualitative Dipstick Ascorbic Acid |
Urinalysis |
11/29/2005 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-1 Parameter Glucose |
| K993850 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
11/29/2005 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-1 Parameter Ketone |
| K993850 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
11/29/2005 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-2 Parameters Glucose/Ketone |
| K993850 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
11/29/2005 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-2 Parameters Glucose/Ketone |
| K993850 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
11/29/2005 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-2 Parameters Glucose/Protein |
| K993850 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
11/29/2005 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-2 Parameters Glucose/Protein |
| K993850 |
Urine Qualitative Dipstick Protein |
Urinalysis |
11/29/2005 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-3 Parameters Glucose/Ketone/Protein |
| K993850 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
11/29/2005 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-3 Parameters Glucose/Ketone/Protein |
| K993850 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
11/29/2005 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-3 Parameters Glucose/Ketone/Protein |
| K993850 |
Urine Qualitative Dipstick Protein |
Urinalysis |
11/29/2005 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/Nitrite/Leukocytes |
| K993850 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
11/29/2005 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/Nitrite/Leukocytes |
| K993850 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
11/29/2005 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/Nitrite/Leukocytes |
| K993850 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
11/29/2005 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/Nitrite/Leukocytes |
| K993850 |
Urine Qualitative Dipstick Protein |
Urinalysis |
11/29/2005 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/pH/Blood |
| K993850 |
Urine Qualitative Dipstick Blood |
Urinalysis |
11/29/2005 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/pH/Blood |
| K993850 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
11/29/2005 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/pH/Blood |
| K993850 |
Urine Qualitative Dipstick pH |
Urinalysis |
11/29/2005 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/pH/Blood |
| K993850 |
Urine Qualitative Dipstick Protein |
Urinalysis |
11/29/2005 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-5 Parameters Glucose/Protein/pH/Blood/Ketone |
| K993850 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
11/29/2005 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-5 Parameters Glucose/Protein/pH/Blood/Ketone |
| K993850 |
Urine Qualitative Dipstick Blood |
Urinalysis |
11/29/2005 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-5 Parameters Glucose/Protein/pH/Blood/Ketone |
| K993850 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
11/29/2005 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-5 Parameters Glucose/Protein/pH/Blood/Ketone |
| K993850 |
Urine Qualitative Dipstick pH |
Urinalysis |
11/29/2005 |
| IND Diagnostic Inc. Urinalysis Reagent Strips-5 Parameters Glucose/Protein/pH/Blood/Ketone |
| K993850 |
Urine Qualitative Dipstick Protein |
Urinalysis |
11/29/2005 |
| Worldwide Medical First Check Multi Drug Cup 7 (OTC) |
| K051966 |
Amphetamines |
Toxicology / TDM |
11/29/2005 |
| Worldwide Medical First Check Multi Drug Cup 7 (OTC) |
| K051966 |
Cannabinoids (THC) |
Toxicology / TDM |
11/29/2005 |
| Worldwide Medical First Check Multi Drug Cup 7 (OTC) |
| K051966 |
Phencyclidine (PCP) |
Toxicology / TDM |
11/29/2005 |
| Worldwide Medical First Check Multi Drug Cup 7 (OTC) |
| K051966 |
Cocaine Metabolites |
Toxicology / TDM |
11/29/2005 |
| Worldwide Medical First Check Multi Drug Cup 7 (OTC) |
| K051966 |
Opiates |
Toxicology / TDM |
11/29/2005 |
| Worldwide Medical First Check Multi Drug Cup 7 (OTC) |
| K051966 |
Methamphetamines |
Toxicology / TDM |
11/29/2005 |
| Worldwide Medical First Check Multi Drug Cup 7 (OTC) |
| K051966 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
11/29/2005 |
| SA Scientific SAS Influenza A Test |
| K041441 |
Influenza A |
Virology |
11/23/2005 |
| SA Scientific SAS Influenza B Test |
| K041439 |
Influenza B |
Virology |
11/23/2005 |
| QuickVue iFOB Test (Immunochemical Fecal Occult Blood) (cassette) |
| K021423 |
Fecal Occult Blood |
General Chemistry |
11/09/2005 |
| Target Corporation EasyPRO Blood Glucose Mornitoring System |
| K020232 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
11/09/2005 |
| CAREONE Sidekick Blood Glucose Testing System |
| K051147 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
10/20/2005 |
| Fisher Scientific Sure-Vue RSV Test |
| K022845 |
Respiratory Syncytial Virus |
Virology |
10/20/2005 |
| Home Diagnostics Inc. Diabetes Centers of America TrueTrack Smart System Blood Glucose Monitoring System |
| K032657 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
10/20/2005 |
| Meridian Bioscience ImmunoCard STAT! RSV PLUS |
| K041445 |
Respiratory Syncytial Virus |
Virology |
10/20/2005 |
| Remel Xpect Rsv |
| K022845 |
Respiratory Syncytial Virus |
Virology |
10/20/2005 |
| SA Scientific SAS RSV Test |
| K022845 |
Respiratory Syncytial Virus |
Virology |
10/20/2005 |
| SA Scientific SAS RSVAlert |
| K022845 |
Respiratory Syncytial Virus |
Virology |
10/20/2005 |
| Care Fecal Occult Blood Test |
| K051806 |
Fecal Occult Blood |
General Chemistry |
10/07/2005 |
| Hypoguard Assure Pro Blood Glucose Monitoring System |
| K051514 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
10/07/2005 |
| Instant Technologies iScreen Mononucleosis Rapid Test Device (Whole Blood) |
| K042272 |
Infectious Mononucleosis Antibodies (Mono) |
General Immunology |
10/07/2005 |
| Instant Technologies iScreen Mononucleosis Rapid Test Strip (Whole Blood) |
| K042272 |
Infectious Mononucleosis Antibodies (Mono) |
General Immunology |
10/07/2005 |
| Taidoc Prodigy Blood Glucose Monitoring System |
| K051854 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
10/07/2005 |
| Hemocue Glucose 201 DM Analyzer |
| K041230 |
Glucose |
General Chemistry |
09/28/2005 |
| Instant Technologies iScreen H. pylori Rapid Test Device |
| K024350 |
Helicobacter Pylori Antibodies |
General Immunology |
09/27/2005 |
| Polymer Technology Systems CardioChek Analyzer {PTS PANELS CHOL+HDL Test Panel Test Strips} |
| K023558 |
HDL Cholesterol |
General Chemistry |
09/27/2005 |
| Polymer Technology Systems CardioChek Analyzer {PTS PANELS CHOL+HDL Test Panel Test Strips} |
| K023558 |
Cholesterol |
General Chemistry |
09/27/2005 |
| Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS CHOL+HDL Test Panel Test Strips} |
| K023558 |
HDL Cholesterol |
General Chemistry |
09/27/2005 |
| Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS CHOL+HDL Test Panel Test Strips} |
| K023558 |
Cholesterol |
General Chemistry |
09/27/2005 |
| ACON Multi-Drug Multi-Line Screen Test Card With Integrated Cup (Professional Use) |
| K050878 |
Amphetamines |
Toxicology / TDM |
09/13/2005 |
| ACON Multi-Drug Multi-Line Screen Test Card With Integrated Cup (Professional Use) |
| K050878 |
Cannabinoids (THC) |
Toxicology / TDM |
09/13/2005 |
| ACON Multi-Drug Multi-Line Screen Test Card With Integrated Cup (Professional Use) |
| K050878 |
Phencyclidine (PCP) |
Toxicology / TDM |
09/13/2005 |
| ACON Multi-Drug Multi-Line Screen Test Card With Integrated Cup (Professional Use) |
| K050878 |
Cocaine Metabolites |
Toxicology / TDM |
09/13/2005 |
| ACON Multi-Drug Multi-Line Screen Test Card With Integrated Cup (Professional Use) |
| K050878 |
Opiates |
Toxicology / TDM |
09/13/2005 |
| ACON Multi-Drug Multi-Line Screen Test Card With Integrated Cup (Professional Use) |
| K050878 |
Methamphetamines |
Toxicology / TDM |
09/13/2005 |
| ACON Multi-Drug Multi-Line Screen Test Card With Integrated Cup (Professional Use) |
| K050878 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
09/13/2005 |
| Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters |
| K993850 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
09/12/2005 |
| Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters |
| K993850 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
09/12/2005 |
| Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters |
| K993850 |
Urine Qualitative Dipstick Blood |
Urinalysis |
09/12/2005 |
| Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters |
| K993850 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
09/12/2005 |
| Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters |
| K993850 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
09/12/2005 |
| Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters |
| K993850 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
09/12/2005 |
| Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters |
| K993850 |
Urine Qualitative Dipstick pH |
Urinalysis |
09/12/2005 |
| Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters |
| K993850 |
Urine Qualitative Dipstick Protein |
Urinalysis |
09/12/2005 |
| Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters |
| K993850 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
09/12/2005 |
| Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters |
| K993850 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
09/12/2005 |
| CVS Sidekick Blood Glucose Test System (Over-The-Counter) |
| K051147 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
09/09/2005 |
| Good Neighbor Pharmacy Sidekick Blood Glucose Test System (Over-The-Counter) |
| K051147 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
09/09/2005 |
| International Newtech Develop. Urinalysis Reagent Strips |
| K993850 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
09/09/2005 |
| International Newtech Develop. Urinalysis Reagent Strips |
| K993850 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
09/09/2005 |
| International Newtech Develop. Urinalysis Reagent Strips |
| K993850 |
Urine Qualitative Dipstick Blood |
Urinalysis |
09/09/2005 |
| International Newtech Develop. Urinalysis Reagent Strips |
| K993850 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
09/09/2005 |
| International Newtech Develop. Urinalysis Reagent Strips |
| K993850 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
09/09/2005 |
| International Newtech Develop. Urinalysis Reagent Strips |
| K993850 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
09/09/2005 |
| International Newtech Develop. Urinalysis Reagent Strips |
| K993850 |
Urine Qualitative Dipstick pH |
Urinalysis |
09/09/2005 |
| International Newtech Develop. Urinalysis Reagent Strips |
| K993850 |
Urine Qualitative Dipstick Protein |
Urinalysis |
09/09/2005 |
| International Newtech Develop. Urinalysis Reagent Strips |
| K993850 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
09/09/2005 |
| International Newtech Develop. Urinalysis Reagent Strips |
| K993850 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
09/09/2005 |
| Leader Sidekick Blood Glucose Test System (Over-The-Counter) |
| K051147 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
09/09/2005 |
| Walgreens Sidekick Blood Glucose Test System (Over-The-Counter) |
| K051147 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
09/09/2005 |
| Roche Diagnostics Accu-Chek Go Blood Glucose Monitoring System |
| K051592 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
09/08/2005 |
| Bayer Clinitek Status Urine Chemistry Analyzer |
| K031947 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
09/07/2005 |
| Bayer Clinitek Status Urine Chemistry Analyzer |
| K031947 |
Urine Qualitative Dipstick Blood |
Urinalysis |
09/07/2005 |
| Bayer Clinitek Status Urine Chemistry Analyzer |
| K031947 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
09/07/2005 |
| Bayer Clinitek Status Urine Chemistry Analyzer |
| K031947 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
09/07/2005 |
| Bayer Clinitek Status Urine Chemistry Analyzer |
| K031947 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
09/07/2005 |
| Bayer Clinitek Status Urine Chemistry Analyzer |
| K031947 |
Urine Qualitative Dipstick pH |
Urinalysis |
09/07/2005 |
| Bayer Clinitek Status Urine Chemistry Analyzer |
| K031947 |
Urine Qualitative Dipstick Protein |
Urinalysis |
09/07/2005 |
| Bayer Clinitek Status Urine Chemistry Analyzer |
| K031947 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
09/07/2005 |
| Bayer Clinitek Status Urine Chemistry Analyzer |
| K031947 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
09/07/2005 |
| Bayer Clinitek Status Urine Chemistry Analyzer |
| K031947 |
Urine Qualitative Dipstick Creatinine |
Urinalysis |
09/07/2005 |
| Bayer Clinitek Status Urine Chemistry Analyzer |
| K031947 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
09/07/2005 |
| accutest Multi-Drug, Multi-Line Screen Device |
| K050050 |
Amphetamines |
Toxicology / TDM |
09/01/2005 |
| accutest Multi-Drug, Multi-Line Screen Device |
| K050050 |
Cannabinoids (THC) |
Toxicology / TDM |
09/01/2005 |
| accutest Multi-Drug, Multi-Line Screen Device |
| K050050 |
Phencyclidine (PCP) |
Toxicology / TDM |
09/01/2005 |
| accutest Multi-Drug, Multi-Line Screen Device |
| K050050 |
Cocaine Metabolites |
Toxicology / TDM |
09/01/2005 |
| accutest Multi-Drug, Multi-Line Screen Device |
| K050050 |
Opiates |
Toxicology / TDM |
09/01/2005 |
| accutest Multi-Drug, Multi-Line Screen Device |
| K050050 |
Methamphetamines |
Toxicology / TDM |
09/01/2005 |
| ACON Mononucleosis Rapid Test Device (Whole Blood) |
| K042272 |
Infectious Mononucleosis Antibodies (Mono) |
General Immunology |
09/01/2005 |
| ACON Mononucleosis Rapid Test Strip (Whole Blood) |
| K042272 |
Infectious Mononucleosis Antibodies (Mono) |
General Immunology |
09/01/2005 |
| RediScreen Multi-Drug, Multi-Line Screen Test Device |
| K050050 |
Amphetamines |
Toxicology / TDM |
09/01/2005 |
| RediScreen Multi-Drug, Multi-Line Screen Test Device |
| K050050 |
Cannabinoids (THC) |
Toxicology / TDM |
09/01/2005 |
| RediScreen Multi-Drug, Multi-Line Screen Test Device |
| K050050 |
Phencyclidine (PCP) |
Toxicology / TDM |
09/01/2005 |
| RediScreen Multi-Drug, Multi-Line Screen Test Device |
| K050050 |
Cocaine Metabolites |
Toxicology / TDM |
09/01/2005 |
| RediScreen Multi-Drug, Multi-Line Screen Test Device |
| K050050 |
Opiates |
Toxicology / TDM |
09/01/2005 |
| RediScreen Multi-Drug, Multi-Line Screen Test Device |
| K050050 |
Methamphetamines |
Toxicology / TDM |
09/01/2005 |
| Biosite Triage Meter (Whole Blood) |
| K021317 |
B-Type Natriuretic Peptide (BNP) |
General Chemistry |
08/26/2005 |
| Biosite Triage Meter Plus (Whole Blood) |
| K021317 |
B-Type Natriuretic Peptide (BNP) |
General Chemistry |
08/26/2005 |
| Acon Laboratories, Inc. FSH One Step Menopause Test Device (Professional Use) |
| K041165 |
Follicle Stimulating Hormone (FSH) |
Endocrinology |
08/24/2005 |
| Acon Laboratories, Inc. FSH One Step Menopause Test Strip (Professional Use) |
| K041165 |
Follicle Stimulating Hormone (FSH) |
Endocrinology |
08/24/2005 |
| Roche Diagnostics AccuChek Instant Plus Dual Testing System |
| K051376 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
08/24/2005 |
| Roche Diagnostics AccuChek Instant Plus Dual Testing System |
| K051376 |
Cholesterol |
General Chemistry |
08/24/2005 |
| Brooks Pharmacy Sidekick Blood Glucose Test System |
| K051147 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
08/22/2005 |
| Eckerd Pharmacy Sidekick Blood Glucose Test System |
| K051147 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
08/22/2005 |
| McKesson SunMark Performance Plus Sidekick Blood Glucose Test System |
| K051147 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
08/22/2005 |
| Medicine Shoppe Sidekick Blood Glucose Test System |
| K051147 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
08/22/2005 |
| Meijer Sidekick Blood Glucose Test System |
| K051147 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
08/22/2005 |
| WH Accu Test One-Step Urine/Serum Pregnancy Test |
| K051841 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
08/22/2005 |
| Abaxis Piccolo Point of Care Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood) |
| K942782 |
Aspartate Aminotransferase (AST) (SGOT) |
General Chemistry |
08/16/2005 |
| Abaxis Piccolo Point of Care Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood) |
| K942782 |
Glucose |
General Chemistry |
08/16/2005 |
| Abaxis Piccolo Point of Care Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood) |
| K950164 |
Alanine Aminotransferase (ALT) (SGPT) |
General Chemistry |
08/16/2005 |
| Abbott Freestyle Connect Blood Glucose Monitoring System |
| K051802 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
08/11/2005 |
| BIOMEDIX INC. Q STEPS Biometer G/C Dual Monitoring System |
| K050182 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
08/11/2005 |
| BIOMEDIX INC. Q STEPS Biometer G/C Dual Monitoring System |
| K050182 |
Cholesterol |
General Chemistry |
08/11/2005 |
| Taidoc Clever Chek TD-3215 Blood Glucose and Blood Pressure Measurement System |
| K051936 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
08/11/2005 |
| Taidoc Dr. T TD-3216 Blood Glucose and Blood Pressure Measurement System |
| K051936 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
08/11/2005 |
| Infopia Co., Ltd. GLucoLab Blood Glucose Monitoring System {Home Use} |
| K051285 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
08/09/2005 |
| Infopia Co., Ltd. GLucoLab Blood Glucose Monitoring System {Professional Use} |
| K051285 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
08/09/2005 |
| Taidoc Clever Chek Blood Glucose Monitoring System TD-4225 |
| K051854 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
08/09/2005 |
| McKesson Corporation Medi-Lab Performance hCG Urine - Cassette |
| K953988 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
08/01/2005 |
| Mizuho USA Proof Positive |
| K000844 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
08/01/2005 |
| Wampole Laboratories Clearview hCG II |
| K953988 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
08/01/2005 |
| Branan Medical Corporation ToxCup Drug Screen Cup |
| K032057 |
Amphetamines |
Toxicology / TDM |
07/19/2005 |
| Branan Medical Corporation ToxCup Drug Screen Cup |
| K032057 |
Cannabinoids (THC) |
Toxicology / TDM |
07/19/2005 |
| Branan Medical Corporation ToxCup Drug Screen Cup |
| K032057 |
Phencyclidine (PCP) |
Toxicology / TDM |
07/19/2005 |
| Branan Medical Corporation ToxCup Drug Screen Cup |
| K032057 |
Cocaine Metabolites |
Toxicology / TDM |
07/19/2005 |
| Branan Medical Corporation ToxCup Drug Screen Cup |
| K032057 |
Opiates |
Toxicology / TDM |
07/19/2005 |
| Branan Medical Corporation ToxCup Drug Screen Cup |
| K032057 |
Methadone |
Toxicology / TDM |
07/19/2005 |
| Branan Medical Corporation ToxCup Drug Screen Cup |
| K032057 |
Methamphetamines |
Toxicology / TDM |
07/19/2005 |
| Branan Medical Corporation ToxCup Drug Screen Cup |
| K032057 |
Benzodiazepines |
Toxicology / TDM |
07/19/2005 |
| Branan Medical Corporation ToxCup Drug Screen Cup |
| K032057 |
Barbiturates |
Toxicology / TDM |
07/19/2005 |
| Branan Medical Corporation ToxCup Drug Screen Cup |
| K032057 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
07/19/2005 |
| Branan Medical Corporation ToxCup Drug Screen Cup |
| K032057 |
Oxycodone |
Toxicology / TDM |
07/19/2005 |
| 3test Blood Glucose Monitoirng System |
| K050224 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
07/14/2005 |
| Home Diagnostics Sidekick Blood Glucose Testing System |
| K051147 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
07/14/2005 |
| Arkray SPOTCHEM EZ Chemistry Analyzer (Whole Blood) |
| K042443 |
Triglyceride |
General Chemistry |
07/12/2005 |
| Arkray SPOTCHEM EZ Chemistry Analyzer (Whole Blood) |
| K042443 |
HDL Cholesterol |
General Chemistry |
07/12/2005 |
| Arkray SPOTCHEM EZ Chemistry Analyzer (Whole Blood) |
| K042443 |
Cholesterol |
General Chemistry |
07/12/2005 |
| Arkray SPOTCHEM EZ Chemistry Analyzer (Whole Blood) |
| K040332 |
Alanine Aminotransferase (ALT) (SGPT) |
General Chemistry |
07/12/2005 |
| Arkray SPOTCHEM EZ Chemistry Analyzer (Whole Blood) |
| K040332 |
Glucose |
General Chemistry |
07/12/2005 |
| Perrigo Company +/- Pregnancy Test |
| K050546 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
07/12/2005 |
| iCassette Multi-Drug, Multi-Line Screen Test Device |
| K050050 |
Amphetamines |
Toxicology / TDM |
07/08/2005 |
| iCassette Multi-Drug, Multi-Line Screen Test Device |
| K050050 |
Cannabinoids (THC) |
Toxicology / TDM |
07/08/2005 |
| iCassette Multi-Drug, Multi-Line Screen Test Device |
| K050050 |
Phencyclidine (PCP) |
Toxicology / TDM |
07/08/2005 |
| iCassette Multi-Drug, Multi-Line Screen Test Device |
| K050050 |
Cocaine Metabolites |
Toxicology / TDM |
07/08/2005 |
| iCassette Multi-Drug, Multi-Line Screen Test Device |
| K050050 |
Opiates |
Toxicology / TDM |
07/08/2005 |
| iCassette Multi-Drug, Multi-Line Screen Test Device |
| K050050 |
Methamphetamines |
Toxicology / TDM |
07/08/2005 |
| Redi-Test Cassette Multi-Drug, Multi-Line Screen Test Device |
| K050050 |
Amphetamines |
Toxicology / TDM |
07/08/2005 |
| Redi-Test Cassette Multi-Drug, Multi-Line Screen Test Device |
| K050050 |
Cannabinoids (THC) |
Toxicology / TDM |
07/08/2005 |
| Redi-Test Cassette Multi-Drug, Multi-Line Screen Test Device |
| K050050 |
Phencyclidine (PCP) |
Toxicology / TDM |
07/08/2005 |
| Redi-Test Cassette Multi-Drug, Multi-Line Screen Test Device |
| K050050 |
Cocaine Metabolites |
Toxicology / TDM |
07/08/2005 |
| Redi-Test Cassette Multi-Drug, Multi-Line Screen Test Device |
| K050050 |
Opiates |
Toxicology / TDM |
07/08/2005 |
| Redi-Test Cassette Multi-Drug, Multi-Line Screen Test Device |
| K050050 |
Methamphetamines |
Toxicology / TDM |
07/08/2005 |
| Acon Laboratories, Inc. On Call Home Drug Test for Marijuana |
| K050936 |
Cannabinoids (THC) |
Toxicology / TDM |
06/30/2005 |
| Acon Laboratories, Inc. On Call Home Drug Test for Marijuana and Cocaine |
| K050936 |
Cannabinoids (THC) |
Toxicology / TDM |
06/30/2005 |
| Acon Laboratories, Inc. On Call Home Drug Test for Marijuana and Cocaine |
| K050936 |
Cocaine Metabolites |
Toxicology / TDM |
06/30/2005 |
| TheraSense FreeStyle 600 Blood Glucose Monitoring System |
| K050500 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/30/2005 |
| Metrika INViEW MULTI-TEST A1C MONITOR (For OTC use) |
| K051321 |
Glycated Hemoglobin, Total |
General Chemistry |
06/15/2005 |
| Metrika INViEW MULTI-TEST A1C MONITOR (For professional use) |
| K051321 |
Glycated Hemoglobin, Total |
General Chemistry |
06/15/2005 |
| ACON Laboratories, On Call Multi-Drug Home Test Cup |
| K050878 |
Amphetamines |
Toxicology / TDM |
06/10/2005 |
| ACON Laboratories, On Call Multi-Drug Home Test Cup |
| K050878 |
Cannabinoids (THC) |
Toxicology / TDM |
06/10/2005 |
| ACON Laboratories, On Call Multi-Drug Home Test Cup |
| K050878 |
Phencyclidine (PCP) |
Toxicology / TDM |
06/10/2005 |
| ACON Laboratories, On Call Multi-Drug Home Test Cup |
| K050878 |
Cocaine Metabolites |
Toxicology / TDM |
06/10/2005 |
| ACON Laboratories, On Call Multi-Drug Home Test Cup |
| K050878 |
Opiates |
Toxicology / TDM |
06/10/2005 |
| ACON Laboratories, On Call Multi-Drug Home Test Cup |
| K050878 |
Methamphetamine/Amphetamine |
Toxicology / TDM |
06/10/2005 |
| Bioscreen Medical One Step Cassette Style hCG Urine (Home) Pregnancy Test |
| K050305 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
06/10/2005 |
| Bioscreen Medical One Step hCG Pregnancy Urine Test Cassette |
| K050305 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
06/10/2005 |
| Bioscreen Medical One Step hCG Pregnancy Urine Test Strip |
| K050305 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
06/10/2005 |
| Bioscreen Medical One Step hCG Pregnancy Urine/Serum Test Cassette |
| K050305 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
06/10/2005 |
| Bioscreen Medical One Step hCG Pregnancy Urine/Serum Test Strip |
| K050305 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
06/10/2005 |
| Bioscreen Medical One Step Midstream Style hCG Urine (Home) Pregnancy Test |
| K050305 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
06/10/2005 |
| Bioscreen Medical One Step Strip Style hCG Urine (Home) Pregnancy Test |
| K050305 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
06/10/2005 |
| Wampole Laboratories Clearview hCG Combo |
| K992187 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
06/10/2005 |
| Wampole Laboratories Clearview hCG Combo with Reference Line |
| K992187 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
06/10/2005 |
| Acon One Step Multi-Drug, Multi-Line Screen Test Device (Professional Use) |
| K050050 |
Amphetamines |
Toxicology / TDM |
06/03/2005 |
| Acon One Step Multi-Drug, Multi-Line Screen Test Device (Professional Use) |
| K050050 |
Cannabinoids (THC) |
Toxicology / TDM |
06/03/2005 |
| Acon One Step Multi-Drug, Multi-Line Screen Test Device (Professional Use) |
| K050050 |
Phencyclidine (PCP) |
Toxicology / TDM |
06/03/2005 |
| Acon One Step Multi-Drug, Multi-Line Screen Test Device (Professional Use) |
| K050050 |
Cocaine Metabolites |
Toxicology / TDM |
06/03/2005 |
| Acon One Step Multi-Drug, Multi-Line Screen Test Device (Professional Use) |
| K050050 |
Opiates |
Toxicology / TDM |
06/03/2005 |
| Acon One Step Multi-Drug, Multi-Line Screen Test Device (Professional Use) |
| K050050 |
Methamphetamines |
Toxicology / TDM |
06/03/2005 |
| Home Diagnostics, Aurora Pharmacy TrueTrack Smart System Blood Glucose System |
| K032657 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/03/2005 |
| Home Diagnostics, Closer Care TrueTrack Smart System Blood Glucose System |
| K032657 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/03/2005 |
| LifesScan OneTouch InDuo Blood Glucose Monitoring System |
| K043197 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/03/2005 |
| LifesScan OneTouch Ultra Blood Glucose Monitoring System |
| K043197 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/03/2005 |
| LifesScan OneTouch UltrasSmart Blood Glucose Monitoring System |
| K043197 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/03/2005 |
| McKesson Corporation Medi-Lab Performance hCG Combo - Cassette |
| K992187 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
06/03/2005 |
| McKesson Corporation Medi-Lab Performance hCG Urine - Dipstick |
| K954444 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
06/03/2005 |
| VIP Diagnostics LLC EZ Smart Blood Glucose Monitoring System |
| K043340 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/03/2005 |
| Wampole Laboratories Clearview hCG II (Dipstick) |
| K954444 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
06/03/2005 |
| Acon +/- Pregnancy Test |
| K050546 |
hCG, Urine |
Endocrinology |
05/23/2005 |
| Pfizer e.p.t Certainty Pregnancy Test |
| K050930 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
05/19/2005 |
| Wampole Laboratories Clearview LH Ovulation Test |
| K924903 |
Ovulation Test (LH) By Visual Color Comparison |
Endocrinology |
05/18/2005 |
| IND Diagnostic One Step hCG Pregnancy Test - Cassette Format |
| K050741 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
05/12/2005 |
| Roche Diagnostics Accu-Chek Integra Blood Glucose Monitoring System |
| K050872 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
05/05/2005 |
| ROCHE DIAGNOSTICS CORP. ACCU-CHEK Aviva System |
| K043474 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
05/02/2005 |
| RAC Medical Clarity HCG Combo Cassettes |
| K974009 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
04/28/2005 |
| RAC Medical Clarity HCG Urine Cassettes |
| K023638 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
04/28/2005 |
| RAC Medical Clarity Ketone Urine Reagent Strips For Urinalysis |
| K993850 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
04/28/2005 |
| RAC Medical Clarity Multistrip Urochek 10 SG Urine Reagent Strips For Urinalysis |
| K993850 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
04/28/2005 |
| RAC Medical Clarity Multistrip Urochek 10 SG Urine Reagent Strips For Urinalysis |
| K993850 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
04/28/2005 |
| RAC Medical Clarity Multistrip Urochek 10 SG Urine Reagent Strips For Urinalysis |
| K993850 |
Urine Qualitative Dipstick Blood |
Urinalysis |
04/28/2005 |
| RAC Medical Clarity Multistrip Urochek 10 SG Urine Reagent Strips For Urinalysis |
| K993850 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
04/28/2005 |
| RAC Medical Clarity Multistrip Urochek 10 SG Urine Reagent Strips For Urinalysis |
| K993850 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
04/28/2005 |
| RAC Medical Clarity Multistrip Urochek 10 SG Urine Reagent Strips For Urinalysis |
| K993850 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
04/28/2005 |
| RAC Medical Clarity Multistrip Urochek 10 SG Urine Reagent Strips For Urinalysis |
| K993850 |
Urine Qualitative Dipstick pH |
Urinalysis |
04/28/2005 |
| RAC Medical Clarity Multistrip Urochek 10 SG Urine Reagent Strips For Urinalysis |
| K993850 |
Urine Qualitative Dipstick Protein |
Urinalysis |
04/28/2005 |
| RAC Medical Clarity Multistrip Urochek 10 SG Urine Reagent Strips For Urinalysis |
| K993850 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
04/28/2005 |
| RAC Medical Clarity Multistrip Urochek 10 SG Urine Reagent Strips For Urinalysis |
| K993850 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
04/28/2005 |
| RAC Medical Clarity Multistrip Urochek US-4 OB |
| K993850 |
Urine Qualitative Dipstick Blood |
Urinalysis |
04/28/2005 |
| RAC Medical Clarity Multistrip Urochek US-4 OB |
| K993850 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
04/28/2005 |
| RAC Medical Clarity Multistrip Urochek US-4 OB |
| K993850 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
04/28/2005 |
| RAC Medical Clarity Multistrip Urochek US-4 OB |
| K993850 |
Urine Qualitative Dipstick Protein |
Urinalysis |
04/28/2005 |
| EPS Bio Technology Easy Pain Supreme Blood Glucose Monitoring System |
| K043245 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
04/27/2005 |
| RAC Medical Clarity Multistrip Urochek US-2 GP Reactive Strip For Urine Detection of 2 Parameters |
| K993850 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
04/27/2005 |
| RAC Medical Clarity Multistrip Urochek US-2 GP Reactive Strip For Urine Detection of 2 Parameters |
| K993850 |
Urine Qualitative Dipstick Protein |
Urinalysis |
04/27/2005 |
| Mizuho USA Proof Positive Electronic Pregnancy Test |
| K043231 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
04/26/2005 |
| PerMaxim RadiScreen H. pylori Test Device (Whole Blood) |
| K024350 |
Helicobacter Pylori Antibodies |
General Immunology |
04/26/2005 |
| RAC Medical Clarity hCG Urine Strips |
| K951705 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
04/26/2005 |
| ReliaLAB Inc. InstaRead Lithium System (fingerstick or venipuncture whole blood) |
| K031579 |
Lithium |
Toxicology / TDM |
04/22/2005 |
| Biotechnostix Rapid Response Strep A Rapid Test Device |
| K023766 |
Streptococcus, Group A |
Bacteriology |
04/21/2005 |
| Biotechnostix Rapid Response Strep A Rapid Test Strip |
| K010582 |
Streptococcus, Group A |
Bacteriology |
04/21/2005 |
| RAC Medical Clarity Strep A Rapid Test Strips |
| K010582 |
Streptococcus, Group A |
Bacteriology |
04/21/2005 |
| RAC Medical Clarity Strep A Twist Rapid Test Device |
| K023766 |
Streptococcus, Group A |
Bacteriology |
04/21/2005 |
| US Diagnostics, Inc. EASYGLUCO Blood Monitoring System |
| K043512 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
04/21/2005 |
| US Diagnostics, Inc. Freedom Blood Glucose Monitoring System |
| K043543 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
04/20/2005 |
| Genzyme Corporation OSOM hCG Combo Test |
| K043385 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
04/18/2005 |
| Wampole Laboratories Clearview RSV |
| K021789 |
Respiratory Syncytial Virus |
Virology |
04/11/2005 |
| Wondfo One Step HCG Urine Pregnancy Test |
| K043443 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
04/08/2005 |
| AFW Alliance Health Care America TrueTrack Smart System, Blood Glucose Monitoring System |
| K032657 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/30/2005 |
| Albertson's Inc. Sav-On Osco By Albertson's TrueTrack Smart System, Blood Glucose Monitoring System |
| K032657 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/30/2005 |
| AmerisourceBergen Brite-Life TrueTrack Smart System, Blood Glucose Monitoring System |
| K032657 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/30/2005 |
| AmerisourceBergen Good Neighbor Pharmacy TrueTrack Smart System, Blood Glucose Monitoring System |
| K032657 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/30/2005 |
| Brooks Pharmacy TrueTrack Smart System, Blood Glucose Monitoring System |
| K032657 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/30/2005 |
| Cardinal Health Leader TrueTrack Smart System, Blood Glucose Monitoring System |
| K032657 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/30/2005 |
| Cardinal Health Your 1st Choice For Value! TrueTrack Smart System, Blood Glucose Monitoring System |
| K032657 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/30/2005 |
| Chain Drug Consortium, LLC Premier Value TrueTrack Smart System, Blood Glucose Monitoring System |
| K032657 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/30/2005 |
| Clarity Hemosure One-Step Immunological Fecal Occult Blood Test |
| K041202 |
Fecal Occult Blood |
General Chemistry |
03/30/2005 |
| CVS Pharmacy Inc. Blood Glucose Monitor, TrueTrack Smart System, Blood Glucose Monitoring System |
| K032657 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/30/2005 |
| Eckerd Drug Company TrueTrack Smart System, Blood Glucose Monitoring System |
| K032657 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/30/2005 |
| Family Pharmacy TrueTrack Smart System, Blood Glucose Monitoring System |
| K032657 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/30/2005 |
| H-E-B inControl Plus Complete Diabetes Monitoring Kit, TrueTrack Smart System, Blood Glucose Monitoring System |
| K032657 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/30/2005 |
| Home Diagnostics Inc. Navarro TrueTrack Smart System, Blood Glucose Monitoring System |
| K032657 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/30/2005 |
| Home Diagnostics, Inc. Discount Drug Mart Food Fair TrueTrack Smart System, Blood Glucose Monitoring System |
| K032657 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/30/2005 |
| Home Diagnostics, TrackEASE Smart System Blood Glucose Monitoring System |
| K032657 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/30/2005 |
| Kmart Corp. American Fare TrueTrack Smart System, Blood Glucose Monitoring System |
| K032657 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/30/2005 |
| Longs Drugs Glucose Monitor TrueTrack Smart System, Blood Glucose Monitoring System |
| K032657 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/30/2005 |
| McKesson Corporation SunMark Performance Plus Blood Glucose Monitoring System, TrueTrack Smart System |
| K032657 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/30/2005 |
| McKesson Sunmark TrueTrack Smart System, Blood Glucose Monitoring System |
| K032657 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/30/2005 |
| Medicine Shoppe International TrueTrack Smart System, Blood Glucose Monitoring System |
| K032657 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/30/2005 |
| Meijer Distribution Inc. Blood Glucose Monitor, TrueTrack Smart System, Blood Glucose Monitoring System |
| K032657 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/30/2005 |
| Preferred Plus Pharmacy TrueTrack Smart System, Blood Glucose Monitoring System |
| K032657 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/30/2005 |
| Walgreens Blood Glucose Monitor, TrueTrack Smart System, Blood Glucose Monitoring System |
| K032657 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/30/2005 |
| Winn-Dixie Stores Inc. (WD) TrueTrack Smart System, Blood Glucose Monitoring System |
| K032657 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/30/2005 |
| Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters) |
| K993850 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
03/29/2005 |
| Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters) |
| K993850 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
03/29/2005 |
| Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters) |
| K993850 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
03/29/2005 |
| Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters) |
| K993850 |
Urine Qualitative Dipstick Blood |
Urinalysis |
03/29/2005 |
| Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters) |
| K993850 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
03/29/2005 |
| Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters) |
| K993850 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
03/29/2005 |
| Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters) |
| K993850 |
Urine Qualitative Dipstick pH |
Urinalysis |
03/29/2005 |
| Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters) |
| K993850 |
Urine Qualitative Dipstick Protein |
Urinalysis |
03/29/2005 |
|