| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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) |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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) |
| K950164 |
Calcium, Total |
General Chemistry |
12/04/2008 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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) |
| K010670 |
chloride |
General Chemistry |
12/04/2008 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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) |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood) |
| K993211 |
Sodium |
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) |
| K992140 |
Creatine Kinase (CK) |
General Chemistry |
12/04/2008 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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) |
| K950164 |
Calcium, Total |
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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 (Whole blood) |
| K053110 |
Hemoglobin |
Hematology |
11/13/2008 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| Abbott i-STAT 6+ Cartridge (Whole blood) |
| K053110 |
Glucose |
General Chemistry |
11/13/2008 |
| Abbott i-STAT 6+ Cartridge (Whole blood) |
| K053110 |
Sodium |
General Chemistry |
11/13/2008 |
| Abbott i-STAT 6+ Cartridge (Whole blood) |
| K053110 |
potassium |
General Chemistry |
11/13/2008 |
| Abbott i-STAT 6+ Cartridge (Whole blood) |
| K053110 |
Urea (BUN) |
General Chemistry |
11/13/2008 |
| Abbott i-STAT 6+ Cartridge (Whole blood) |
| K053110 |
chloride |
General Chemistry |
11/13/2008 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| Abbott i-STAT 6+ Cartridge (Whole blood) |
| K053110 |
Hematocrit |
Hematology |
11/13/2008 |
| Abbott i-STAT Crea Cartridge (Whole blood) |
| K053110 |
Creatinine |
General Chemistry |
11/13/2008 |
| Abbott i-STAT E3+ Cartridge (Whole blood) |
| K053110 |
Hemoglobin |
Hematology |
11/13/2008 |
| Abbott i-STAT E3+ Cartridge (Whole blood) |
| K053110 |
Sodium |
General Chemistry |
11/13/2008 |
| Abbott i-STAT E3+ Cartridge (Whole blood) |
| K053110 |
potassium |
General Chemistry |
11/13/2008 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| Abbott i-STAT E3+ Cartridge (Whole blood) |
| K053110 |
Hematocrit |
Hematology |
11/13/2008 |
| Abbott i-STAT EC4+ Cartridge (Whole blood) |
| K053110 |
Hemoglobin |
Hematology |
11/13/2008 |
| Abbott i-STAT EC4+ Cartridge (Whole blood) |
| K053110 |
Glucose |
General Chemistry |
11/13/2008 |
| Abbott i-STAT EC4+ Cartridge (Whole blood) |
| K053110 |
Sodium |
General Chemistry |
11/13/2008 |
| Abbott i-STAT EC4+ Cartridge (Whole blood) |
| K053110 |
potassium |
General Chemistry |
11/13/2008 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| Abbott i-STAT EC4+ Cartridge (Whole blood) |
| K053110 |
Hematocrit |
Hematology |
11/13/2008 |
| Abbott i-STAT G Cartridge (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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| Clever Chek Auto-Code Voice Blood Glucose Monitoring System |
| K081144 |
Glucose |
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 |
|