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CLIA - Tests waived by FDA from January 2000 to present

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Tests can be categorized as "waived" from regulatory oversite if they meet certain requirements established by the Clinical Laboratory Improvement Amendments of 1988 (CLIA) law. By selecting a Test System Name, you can view the CLIA data for that Test System, including the corresponding 510(K) record, if applicable. The information is sorted first by the date of Categorization of the Test, then by Test System Name. This list does not include Test Systems that were characterized by the CDC prior to January 2000.
 
 
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Show All Test Systems Download Files | More About CLIA
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Home Diagnostics, TRUEbalance Blood Glucose Monitoring System  
K090495 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/30/2009
Henry Schein OneStep+ iFOBT  
K060463 Fecal Occult Blood General Chemistry 03/05/2009
Home Diagnostics GRACEtrack Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/18/2009
Home Diagnostics TRUEresult Blood Glucose Monitoring System  
K080641 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/20/2008
Home Diagnostics TRUE2go Blood Glucose Monitoring System  
K080710 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/15/2008
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
Healthcare Provider Direct OneStep Fecal Occult Blood (FOB) Screen Card Test  
K063693 Fecal Occult Blood General Chemistry 07/22/2008
Henry Schein One Step+ Strep A Dipstick Test  
K010582 Streptococcus, Group A Bacteriology 07/17/2008
HemoCue Albumin 201 System  
K053253 Albumin, Urinary General Chemistry 06/13/2008
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
Home Diagnostics, Preferred Plus Pharmacy TRUEread Blood Glucose Monitoring System  
K042080 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/29/2008
HMD Biomedical Llc Evolution Blood Glucose Monitoring System  
K072369 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/26/2008
Henry Schein One Step + Strep A Cassette Test  
K023766 Streptococcus, Group A Bacteriology 03/04/2008
Henry Schein One Step + Mononucleosis Rapid Test Device  (Whole Blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 02/26/2008
Heritage House '76 Inc., The Precious Feet Premium Pregnancy Test  
K050741 Urine hCG By Visual Color Comparison Tests Endocrinology 10/24/2007
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
Henry Schein One Step + H. Pylori Rapid Test Device {Whole Blood} (H. Pylori)
K024350 Helicobacter Pylori Antibodies General Immunology 07/25/2007
HENRY SCHEIN ONE STEP+ MONO TEST  (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
HemoCue Hb 301 System  
K061047 Hemoglobin Hematology 04/12/2007
Home Diagnostics, TRUEread Blood Glucose Monitoring System  
K042080 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/28/2007
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
HemoCue Hb 301 System  
K061047 Hemoglobin Hematology 10/10/2006
Home Diagnostics Element Blood Glucose Monitoring System  
K060793 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/27/2006
HealthPia America Corporation, GlucoPack Blood Glucose Monitoring System  
K052469 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/15/2006
Hypoguard Assure Pro Blood Glucose Monitoring System  
K053079 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2006
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
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
Hypoguard Assure Pro Blood Glucose Monitoring System  
K051514 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/07/2005
Hemocue Glucose 201 DM Analyzer  
K041230 Glucose General Chemistry 09/28/2005
Home Diagnostics Sidekick Blood Glucose Testing System  
K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/14/2005
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
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
Home Diagnostics Diabetics Experts Of America Blood Glucose System  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/16/2005
Home Diagnostics, Equaline TrueTrack Smart System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/16/2005
Home Diagnostics, Publix TrueTrack Smart System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/16/2005
Home Diagnostics, Safeway TrueTrack Smart System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/16/2005
Hypoguard Advance Micro-Draw Blood Glucose Monitoring System  
K020232 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/10/2005
Howard Medical Company OneStep Pregnancy  
K980531 Urine hCG By Visual Color Comparison Tests Endocrinology 03/09/2005
Henry Schein One Step+ hCG Strip Test  
K954444 Urine hCG By Visual Color Comparison Tests Endocrinology 02/18/2005
Henry Schein One Step+ hCG Test  
K953988 Urine hCG By Visual Color Comparison Tests Endocrinology 02/18/2005
Henry Schein One Step+ hCG Combo Test  
K992187 Urine hCG By Visual Color Comparison Tests Endocrinology 02/17/2005
HOME DIAGNOSTICS INVACARE QUALITY ALTERNATIVES BLOOD GLUCOSE MONITOR - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/15/2005
HOME DIAGNOSTICS MCKESSON SUNMARK PERFORMANCE BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/15/2005
HOME DIAGNOSTICS MP TOTAL CARE BLOOD GLUCOSE TEST STRIPS - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/15/2005
HOME DIAGNOSTICS NATIONAL RURAL ELECTRIC COOPERATIVE ASSOCIATION BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/15/2005
HOME DIAGNOSTICS STAR MEDICAL BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/15/2005
HOWARD MEDICAL COMPANY ONESTEP PLUS PREGNANCY  
K981165 Urine hCG By Visual Color Comparison Tests Endocrinology 12/29/2004
HENRY SCHEIN ONE STEP+ MONO TEST  
K973559 Infectious Mononucleosis Antibodies (Mono) General Immunology 12/09/2004
HOME DIAGNOSTICS, CAREONE TRUETRACK SMART SYSTEM  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/09/2004
HOME DIAGNOSTICS, DUANE READE TRUE TRACK SMART SYSTEM  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/09/2004
HOME DIAGNOSTICS, FASA BLOOD GLUCOSE MONITORING SYSTEM (PRESTIGE SMART SYSTEM IQ)  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/09/2004
HOME DIAGNOSTICS, INVACARE TRUETRACK SMART SYSTEM  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/09/2004
HOME DIAGNOSTICS, MMM MEDICARE Y MUCHA MAS BLOOD GLUCOSE MONITORING SYSTEM (PRESTIGE SMART SYSTEM IQ)  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/09/2004
HOME DIAGNOSTICS, MOLINA HEALTHCARE TRUETRACK SMART SYSTEM  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/09/2004
Henry Schein One Step+ Strep A Dipstick Test  
K033855 Streptococcus, Group A Bacteriology 10/29/2004
HENRY SCHEIN ONESTEP+ H. PYLORI TEST  
K990892 Helicobacter Pylori Antibodies General Immunology 10/29/2004
HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST  
K041202 Fecal Occult Blood General Chemistry 09/08/2004
HYPOGUARD ADVANCE INTUITION BLOOD GLUCOSE MONITORING SYSTEM  
K002621 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/01/2004
HOME DIAGNOSTICS, TRACKEASE SMART SYSTEM BLOOD GLUCOSE METER  
K042080 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/27/2004
HYPOGUARD ADVANCE INTUITION BLOOD GLUCOSE MONITORING SYSTEM  
K011233 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/27/2004
Hypoguard Advance Micro-Draw Blood Glucose Monitoring System  
K031388 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/27/2004
HEMOCUE HB 201+SYSTEM  (CAPILLARY, VENOUS, ARTERIAL WHOLE BLOOD)
K032203 HGB, SINGLE ANALYTE INST. W/SELF-CONT... Hematology 06/30/2004
HEMOCUE HB 201 DM ANALYZING SYSTEM  
K041234 Hemoglobin Hematology 06/28/2004
HEMOCUE HEMOGLOBIN 201 + / HEMOCUE HEMOGLOBIN MICROCUVETTE SYSTEM  
K032203 HGB, SINGLE ANALYTE INST. W/SELF-CONT... Hematology 05/04/2004
HOME DIAGNOSTICS, TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/25/2004
HYPOGUARD DIASCREEN REAGENT STRIPS FOR URINALYSIS GLUCOSE/KETONES  (Over-The-Counter)
K033851 Urine Qualitative Dipstick Ketone Urinalysis 03/02/2004
HYPOGUARD DIASCREEN REAGENT STRIPS FOR URINALYSIS GLUCOSE/KETONES  (Over-The-Counter)
K033851 Urine Qualitative Dipstick Glucose Urinalysis 03/02/2004
HEMOCARE  
K840527 Fecal Occult Blood General Chemistry 02/23/2004
HOME DIAGNOSTICS, BRITE-LIFE TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/09/2004
HOME DIAGNOSTICS, BROOKS TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/09/2004
HOME DIAGNOSTICS, DISCOUNT DRUG MART FOOD FAIR TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/09/2004
HOME DIAGNOSTICS, HEALTH CARE AMERICA TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/09/2004
HOME DIAGNOSTICS, NAVARRO TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/09/2004
HOME DIAGNOSTICS, PREFERRED PLUS PHARMACY TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/09/2004
HOME DIAGNOSTICS, WINN DIXIE (WD) TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/09/2004
HOME DIAGNOSTICS, AMERICAN FARE TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/17/2003
HOME DIAGNOSTICS, ECKERD TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/17/2003
HOME DIAGNOSTICS, FAMILY PHARMACY TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/17/2003
HOME DIAGNOSTICS, GOOD NEIGHBOR PHARMACY TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/17/2003
HOME DIAGNOSTICS, HEB IN CONTROL PLUS BLOOD GLUCOSE SYSTEM, TRUETRACK SMART SYSTEM  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/17/2003
HOME DIAGNOSTICS, MCKESSON SUNMARK PERFORMANCE PLUS BLOOD GLUCOSE SYSTEM, TRUETRACK SMART SYSTEM  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/17/2003
HOME DIAGNOSTICS, PREMIER VALUE TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/17/2003
Home Diagnostics, TrackEASE Smart System Blood Glucose Monitoring System, Truetrack Smart System  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/17/2003
HMD BIOMEDICAL GLUCOLEADER ENHANCE BLOOD GLUCOSE MONITORING SYSTEM  
K032985 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/21/2003
HMD BIOMEDICAL GLUCOLEADER VALUE GLUCOSE METER  
K023279 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/01/2003
HOME DIAGNOSTICS, TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/10/2003
HOME DIAGNOSTICS MCKESSON SUNMARK BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/12/2003
HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM  
K031388 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/23/2003
HEMOCUE DONOR HEMOGLOBIN CHECKER SYSTEM  
BK030020 HGB, SINGLE ANALYTE INST. W/SELF-CONT... Hematology 05/14/2003
HOME DIAGNOSTICS DUANE READE BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/13/2003
HERITAGE HOUSE '76, INC. PRECIOUS FEET PREGNANCY TEST  
K023638 Urine hCG By Visual Color Comparison Tests Endocrinology 02/06/2003
Hypoguard, DiaScreen 50 Urine Chemistry Analyzer  
K010973 Urine Qualitative Dipstick Ketone Urinalysis 12/06/2002
Hypoguard, DiaScreen 50 Urine Chemistry Analyzer  
K010973 Urine Qualitative Dipstick Bilirubin Urinalysis 12/06/2002
Hypoguard, DiaScreen 50 Urine Chemistry Analyzer  
K010973 Urine Qualitative Dipstick Blood Urinalysis 12/06/2002
Hypoguard, DiaScreen 50 Urine Chemistry Analyzer  
K010973 Urine Qualitative Dipstick Glucose Urinalysis 12/06/2002
Hypoguard, DiaScreen 50 Urine Chemistry Analyzer  
K010973 Urine Qualitative Dipstick Leukocytes Urinalysis 12/06/2002
Hypoguard, DiaScreen 50 Urine Chemistry Analyzer  
K010973 Urine Qualitative Dipstick Nitrite Urinalysis 12/06/2002
Hypoguard, DiaScreen 50 Urine Chemistry Analyzer  
K010973 Urine Qualitative Dipstick pH Urinalysis 12/06/2002
Hypoguard, DiaScreen 50 Urine Chemistry Analyzer  
K010973 Urine Qualitative Dipstick Protein Urinalysis 12/06/2002
Hypoguard, DiaScreen 50 Urine Chemistry Analyzer  
K010973 Urine Qualitative Dipstick Urobilinogen Urinalysis 12/06/2002
Hypoguard, DiaScreen 50 Urine Chemistry Analyzer  
K010973 Urine Qualitative Dipstick Specific Gravity Urinalysis 12/06/2002
HEMOSENSE INRATIO SYSTEM  
K020679 Prothrombin Time (PT) Hematology 12/03/2002
HOME DIAGNOSTICS MEDLINE BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/08/2002
HOME DIAGNOSTICS SHOPRITE BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/08/2002
HENRY SCHEIN ONE STEP+ STREP A TEST  
K992658 Streptococcus, Group A Bacteriology 10/23/2002
HYPOGUARD GLUCOBALANCE DATA MANAGEMENT SOFTWARE  
K022545 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/08/2002
HERITAGE HOUSE '76, INC. PRECIOUS FEET PREGNANCY TEST  
K980531 Urine hCG By Visual Color Comparison Tests Endocrinology 09/09/2002
HOME DIAGNOSTICS PRESTIGE IQ BLOOD GLUCOSE SYSTEM {CHAY MEDICAL 3 MICROLITER EXCELSIOR TEST STRIPS} 
K021781 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/29/2002
HOME DIAGNOSTICS PRESTIGE LX BLOOD GLUCOSE SYSTEM {CHAY MEDICAL 3 MICROLITER EXCELSIOR TEST STRIPS} 
K021781 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/29/2002
HEMOCUE GLUCOSE 201 MICROCUVETTES AND GLUCOSE 201 ANALYZER WITH PLASMA CONVERSION  
K020935 Glucose General Chemistry 07/12/2002
HENRY SCHEIN ONESTEP + HCG STRIP TEST  
K941090 Urine hCG By Visual Color Comparison Tests Endocrinology 06/12/2002
HENRY SCHEIN ONESTEP + HCG TEST  
K941090 Urine hCG By Visual Color Comparison Tests Endocrinology 06/12/2002
HYPOGUARD ASSURE BLOOD GLUCOSE SYSTEM  
K980573 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/21/2002
Hypoguard Assure II Blood Glucose Monitoring System  
K002621 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/21/2002
HYPOGUARD DIASCREEN 10  
K981555 Urine Qualitative Dipstick Ketone Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 10  
K981555 Urine Qualitative Dipstick Bilirubin Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 10  
K981555 Urine Qualitative Dipstick Blood Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 10  
K981555 Urine Qualitative Dipstick Glucose Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 10  
K981555 Urine Qualitative Dipstick Leukocytes Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 10  
K981555 Urine Qualitative Dipstick Nitrite Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 10  
K981555 Urine Qualitative Dipstick pH Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 10  
K981555 Urine Qualitative Dipstick Protein Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 10  
K981555 Urine Qualitative Dipstick Urobilinogen Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 10  
K981555 Urine Qualitative Dipstick Specific Gravity Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 1B  
K981555 Urine Qualitative Dipstick Blood Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 40BL  
K981555 Urine Qualitative Dipstick Blood Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 40BL  
K981555 Urine Qualitative Dipstick Glucose Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 40BL  
K981555 Urine Qualitative Dipstick Leukocytes Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 40BL  
K981555 Urine Qualitative Dipstick Protein Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 4NL  
K981555 Urine Qualitative Dipstick Glucose Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 4NL  
K981555 Urine Qualitative Dipstick Leukocytes Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 4NL  
K981555 Urine Qualitative Dipstick Nitrite Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 4PH  
K981555 Urine Qualitative Dipstick Blood Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 4PH  
K981555 Urine Qualitative Dipstick Glucose Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 4PH  
K981555 Urine Qualitative Dipstick Leukocytes Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 4PH  
K981555 Urine Qualitative Dipstick Nitrite Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 4PH  
K981555 Urine Qualitative Dipstick pH Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 4PH  
K981555 Urine Qualitative Dipstick Protein Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 9  
K981555 Urine Qualitative Dipstick Blood Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 9  
K981555 Urine Qualitative Dipstick Glucose Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 9  
K981555 Urine Qualitative Dipstick Nitrite Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 9  
K981555 Urine Qualitative Dipstick pH Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 9  
K981555 Urine Qualitative Dipstick Protein Urinalysis 05/17/2002
HYPOGUARD DIASCREEN 9  
K981555 Urine Qualitative Dipstick Urobilinogen Urinalysis 05/17/2002
HENRY SCHEIN ONE STEP SLIDE TEST FOR FECAL OCCULT BLOOD  
K902360 Fecal Occult Blood General Chemistry 04/05/2002
HOME DIAGNOSTICS BROOKS BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/12/2002
HOME DIAGNOSTICS ECKERD BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/12/2002
HOME DIAGNOSTICS KERR DRUG BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/12/2002
HOME DIAGNOSTICS PREFERRED PLUS PHARMACY BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/12/2002
HOME DIAGNOSTICS VALU-RITE BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/12/2002
HOME DIAGNOSTICS PRESTIGE IQ BLOOD GLUCOSE SYSTEM {CHAY MEDICAL EXCELSIOR TEST STRIPS} 
K013342 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/07/2002
HOME DIAGNOSTICS PRESTIGE LX BLOOD GLUCOSE SYSTEM {CHAY MEDICAL EXCELSIOR TEST STRIPS} 
K013342 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/07/2002
HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM  
K020232 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/07/2002
HOME DIAGNOSTICS LIFE MEDICAL BLOOD GLUCOSE SYSTEM  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/17/2001
HOME DIAGNOSTICS LONGS BLOOD GLUCOSE SYSTEM  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/17/2001
HOME DIAGNOSTICS MEIJER BLOOD GLUCOSE SYSTEM  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/17/2001
HYPOGUARD ASSURE BLOOD GLUCOSE SYSTEM  
K002621 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/17/2001
Hypoguard Assure II Blood Glucose Monitoring System  
K011233 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/17/2001
HOME DIAGNOSTICS AMERICAN FARE BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/19/2001
HOME DIAGNOSTICS FAMILY PHARMACY BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/19/2001
HOME DIAGNOSTICS HEALTH CARE AMERICA BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/19/2001
HOME DIAGNOSTICS HEB INCONTROL BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/19/2001
HOME DIAGNOSTICS NAVARRO BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/19/2001
HOME DIAGNOSTICS PATHMARK BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/19/2001
HOME DIAGNOSTICS HOMEBEST BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/06/2001
HOME DIAGNOSTICS LEADER BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/06/2001
HOME DIAGNOSTICS MEDIC DIRECT BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/06/2001
HOME DIAGNOSTICS PHARMOR BLOOD GLUCOSE SYSTEM - IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/06/2001
HYPOGUARD DIASCREEN REAGENT STRIPS FOR URINALYSIS  
K010973 Urine Dipstick Or Tablet Analytes, Nonautomated Urinalysis 09/21/2001
HOME DIAGNOSTICS GAMBRO BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/31/2001
HOME DIAGNOSTICS WALGREENS BLOOD GLUCOSE SYSTEM  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/31/2001
HYPOGUARD QUICKTEK BLOOD GLUCOSE METER  
K010039 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/28/2001
HOME DIAGNOSTICS MEDICINE SHOPPE BLOOD GLUCOSE SYSTEM  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/20/2001
HOME DIAGNOSTICS APICAL BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/03/2001
HOME DIAGNOSTICS BROOKS PHARMACY BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/03/2001
HOME DIAGNOSTICS DIABETIC.COM BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/03/2001
HOME DIAGNOSTICS EPIC PHARMACIES BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/03/2001
HOME DIAGNOSTICS FARMACIAS EL AMAL BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/03/2001
HOME DIAGNOSTICS MEDPLUS PHARMACY BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/03/2001
HOME DIAGNOSTICS PRESTIGE IQ BLOOD GLUCOSE SYSTEM  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/27/2001
HOME DIAGNOSTICS GENICARE BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/26/2001
HOME DIAGNOSTICS MEDHOME DIRECT BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/26/2001
HOME DIAGNOSTICS PHARMOR BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/26/2001
HOME DIAGNOSTICS VITALCARE BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/26/2001
HEALTH CARE AMERICA BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/22/2001
HUMANA BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/22/2001
HELENA LABORATORIES COLOSCREEN-ES  
K003359 Fecal Occult Blood General Chemistry 12/13/2000
HOME DIAGNOSTICS NAVARRO BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/09/2000
 
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