Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
-

CLIA - Tests waived by FDA from January 2000 to present

see related
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.
 
 
 1 
 3 
 A 
 B 
 C 
 D 
 E 
 F 
 G 
 H 
 I 
 J 
 K 
 L 
 M 
 N 
 O 
 P 
 Q 
 R 
 S 
 T 
 U 
 V 
 W 
 Y 
 Z 
 
 
Show All Test Systems Download Files | More About CLIA
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
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
ReliOn micro Blood Glucose Monitoring System  
K082417 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/05/2009
Roche Diagnostics ACCU-CHEK Compact Plus Blood Glucose Meter  
K081389 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/22/2008
Rush Industries Ovulation Test  
X050002 Ovulation Test (LH) By Visual Color Comparison Endocrinology 06/25/2007
Roche Diagnostics Corp. ACCU-CHEK Performa System  
K070585 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/31/2007
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
Roche Diagnostics CoaguChek XS   
K060978 Prothrombin Time (PT) Hematology 03/23/2007
Rush Industries Rush Pregnancy Test  
K974059 Urine hCG By Visual Color Comparison Tests Endocrinology 03/19/2007
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
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
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
Rapid Pathogen Screening RPS Adeno Detector  
K052092 Adenovirus Virology 03/30/2006
RAC Medical Clarity MONO Mononucleosis Rapid Test Device  (Whole Blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 02/22/2006
RAC Medical Clarity FSH One Step Menopause Test Device  (Professional Use)
K041165 Follicle Stimulating Hormone (FSH) Endocrinology 01/10/2006
Rapid Response Mononucleosis Rapid Test Device (whole blood)  
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 12/15/2005
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
Remel Xpect Rsv  
K022845 Respiratory Syncytial Virus Virology 10/20/2005
Roche Diagnostics Accu-Chek Go Blood Glucose Monitoring System  
K051592 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/08/2005
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
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
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
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
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
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
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
Redwood Biotech, Inc. Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Ketone Urinalysis 03/02/2005
Redwood Biotech, Inc. Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Bilirubin Urinalysis 03/02/2005
Redwood Biotech, Inc. Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Blood Urinalysis 03/02/2005
Redwood Biotech, Inc. Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Glucose Urinalysis 03/02/2005
Redwood Biotech, Inc. Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Leukocytes Urinalysis 03/02/2005
Redwood Biotech, Inc. Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Nitrite Urinalysis 03/02/2005
Redwood Biotech, Inc. Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick pH Urinalysis 03/02/2005
Redwood Biotech, Inc. Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Protein Urinalysis 03/02/2005
Redwood Biotech, Inc. Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Urobilinogen Urinalysis 03/02/2005
Redwood Biotech, Inc. Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Specific Gravity Urinalysis 03/02/2005
Redwood Biotech, Inc. Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 03/02/2005
Roche Diagnostics Accu-Chek Go Blood Glucose Monitoring System  
K040796 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/26/2004
REDWOOD BIOTECH URINE REAGENT STRIPS-10  
K991927 Urine Qualitative Dipstick Ketone Urinalysis 12/17/2003
REDWOOD BIOTECH URINE REAGENT STRIPS-10  
K991927 Urine Qualitative Dipstick Bilirubin Urinalysis 12/17/2003
REDWOOD BIOTECH URINE REAGENT STRIPS-10  
K991927 Urine Qualitative Dipstick Blood Urinalysis 12/17/2003
REDWOOD BIOTECH URINE REAGENT STRIPS-10  
K991927 Urine Qualitative Dipstick Glucose Urinalysis 12/17/2003
REDWOOD BIOTECH URINE REAGENT STRIPS-10  
K991927 Urine Qualitative Dipstick Leukocytes Urinalysis 12/17/2003
REDWOOD BIOTECH URINE REAGENT STRIPS-10  
K991927 Urine Qualitative Dipstick Nitrite Urinalysis 12/17/2003
REDWOOD BIOTECH URINE REAGENT STRIPS-10  
K991927 Urine Qualitative Dipstick pH Urinalysis 12/17/2003
REDWOOD BIOTECH URINE REAGENT STRIPS-10  
K991927 Urine Qualitative Dipstick Protein Urinalysis 12/17/2003
REDWOOD BIOTECH URINE REAGENT STRIPS-10  
K991927 Urine Qualitative Dipstick Urobilinogen Urinalysis 12/17/2003
REDWOOD BIOTECH URINE REAGENT STRIPS-10  
K991927 Urine Qualitative Dipstick Specific Gravity Urinalysis 12/17/2003
ROCHE DIAGNOSTICS, URISYS 1100 URINE ANALYZER  
K033548 Urine Qualitative Dipstick Ketone Urinalysis 12/17/2003
ROCHE DIAGNOSTICS, URISYS 1100 URINE ANALYZER  
K033548 Urine Qualitative Dipstick Bilirubin Urinalysis 12/17/2003
ROCHE DIAGNOSTICS, URISYS 1100 URINE ANALYZER  
K033548 Urine Qualitative Dipstick Blood Urinalysis 12/17/2003
ROCHE DIAGNOSTICS, URISYS 1100 URINE ANALYZER  
K033548 Urine Qualitative Dipstick Glucose Urinalysis 12/17/2003
ROCHE DIAGNOSTICS, URISYS 1100 URINE ANALYZER  
K033548 Urine Qualitative Dipstick Leukocytes Urinalysis 12/17/2003
ROCHE DIAGNOSTICS, URISYS 1100 URINE ANALYZER  
K033548 Urine Qualitative Dipstick Nitrite Urinalysis 12/17/2003
ROCHE DIAGNOSTICS, URISYS 1100 URINE ANALYZER  
K033548 Urine Qualitative Dipstick pH Urinalysis 12/17/2003
ROCHE DIAGNOSTICS, URISYS 1100 URINE ANALYZER  
K033548 Urine Qualitative Dipstick Protein Urinalysis 12/17/2003
ROCHE DIAGNOSTICS, URISYS 1100 URINE ANALYZER  
K033548 Urine Qualitative Dipstick Urobilinogen Urinalysis 12/17/2003
ROCHE DIAGNOSTICS, URISYS 1100 URINE ANALYZER  
K033548 Urine Qualitative Dipstick Specific Gravity Urinalysis 12/17/2003
ROCHE DIAGNOSTICS CHEMSTRIP 101 URINE ANALYZER  
K032437 Urine Qualitative Dipstick Ketone Urinalysis 12/05/2003
ROCHE DIAGNOSTICS CHEMSTRIP 101 URINE ANALYZER  
K032437 Urine Qualitative Dipstick Bilirubin Urinalysis 12/05/2003
ROCHE DIAGNOSTICS CHEMSTRIP 101 URINE ANALYZER  
K032437 Urine Qualitative Dipstick Blood Urinalysis 12/05/2003
ROCHE DIAGNOSTICS CHEMSTRIP 101 URINE ANALYZER  
K032437 Urine Qualitative Dipstick Glucose Urinalysis 12/05/2003
ROCHE DIAGNOSTICS CHEMSTRIP 101 URINE ANALYZER  
K032437 Urine Qualitative Dipstick Leukocytes Urinalysis 12/05/2003
ROCHE DIAGNOSTICS CHEMSTRIP 101 URINE ANALYZER  
K032437 Urine Qualitative Dipstick Nitrite Urinalysis 12/05/2003
ROCHE DIAGNOSTICS CHEMSTRIP 101 URINE ANALYZER  
K032437 Urine Qualitative Dipstick pH Urinalysis 12/05/2003
ROCHE DIAGNOSTICS CHEMSTRIP 101 URINE ANALYZER  
K032437 Urine Qualitative Dipstick Protein Urinalysis 12/05/2003
ROCHE DIAGNOSTICS CHEMSTRIP 101 URINE ANALYZER  
K032437 Urine Qualitative Dipstick Urobilinogen Urinalysis 12/05/2003
ROCHE DIAGNOSTICS CHEMSTRIP 101 URINE ANALYZER  
K032437 Urine Qualitative Dipstick Specific Gravity Urinalysis 12/05/2003
REDWOOD BIOTECH FECAL OCCULT BLOOD TEST  
K902360 Fecal Occult Blood General Chemistry 09/25/2003
ROCHE DIAGNOSTICS ACCU-CHEK ADVANTAGE III  
K032552 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/10/2003
ROCHE DIAGNOSTICS ACCU-CHEK COMPACT TEST SYSTEM  
K031755 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/03/2003
ROCHE DIAGNOSTICS COAGUCHEK {PT-S TEST STRIPS} 
K021190 Prothrombin Time (PT) Hematology 06/18/2003
ROCHE DIAGNOSTICS CHEMSTRIP 5 OB  
K896454 Urine Qualitative Dipstick Blood Urinalysis 05/01/2003
ROCHE DIAGNOSTICS CHEMSTRIP 5 OB  
K896454 Urine Qualitative Dipstick Glucose Urinalysis 05/01/2003
ROCHE DIAGNOSTICS CHEMSTRIP 5 OB  
K896454 Urine Qualitative Dipstick Leukocytes Urinalysis 05/01/2003
ROCHE DIAGNOSTICS CHEMSTRIP 5 OB  
K896454 Urine Qualitative Dipstick Nitrite Urinalysis 05/01/2003
ROCHE DIAGNOSTICS CHEMSTRIP 5 OB  
K896454 Urine Qualitative Dipstick Protein Urinalysis 05/01/2003
ROCHE DIAGNOSTICS CHEMSTRIP 7  
K896454 Urine Qualitative Dipstick Ketone Urinalysis 05/01/2003
ROCHE DIAGNOSTICS CHEMSTRIP 7  
K896454 Urine Qualitative Dipstick Blood Urinalysis 05/01/2003
ROCHE DIAGNOSTICS CHEMSTRIP 7  
K896454 Urine Qualitative Dipstick Glucose Urinalysis 05/01/2003
ROCHE DIAGNOSTICS CHEMSTRIP 7  
K896454 Urine Qualitative Dipstick Leukocytes Urinalysis 05/01/2003
ROCHE DIAGNOSTICS CHEMSTRIP 7  
K896454 Urine Qualitative Dipstick Nitrite Urinalysis 05/01/2003
ROCHE DIAGNOSTICS CHEMSTRIP 7  
K896454 Urine Qualitative Dipstick pH Urinalysis 05/01/2003
ROCHE DIAGNOSTICS CHEMSTRIP 7  
K896454 Urine Qualitative Dipstick Protein Urinalysis 05/01/2003
Roche Diagnostics CoaguChek S System {PT-S TEST STRIPS} 
K020831 Prothrombin Time (PT) Hematology 11/14/2002
ROCHE DIAGNOSTICS COAGUCHEK {PT-S TEST STRIPS} 
K021190 Prothrombin Time (PT) Hematology 11/12/2002
ROCHE DIAGNOSTICS ACCU-CHEK COMPACT TEST SYSTEM  
K022171 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/22/2002
ROCHE DIAGNOSTICS ACCU-CHEK ACTIVE SYSTEM  
K021827 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/02/2002
ROCHE DIAGNOSTICS CHEMSTRIP 10 MD TEST STRIPS  
K983510 Urine Qualitative Dipstick Ketone Urinalysis 06/07/2002
ROCHE DIAGNOSTICS CHEMSTRIP 10 MD TEST STRIPS  
K983510 Urine Qualitative Dipstick Bilirubin Urinalysis 06/07/2002
ROCHE DIAGNOSTICS CHEMSTRIP 10 MD TEST STRIPS  
K983510 Urine Qualitative Dipstick Blood Urinalysis 06/07/2002
ROCHE DIAGNOSTICS CHEMSTRIP 10 MD TEST STRIPS  
K983510 Urine Qualitative Dipstick Glucose Urinalysis 06/07/2002
ROCHE DIAGNOSTICS CHEMSTRIP 10 MD TEST STRIPS  
K983510 Urine Qualitative Dipstick Leukocytes Urinalysis 06/07/2002
ROCHE DIAGNOSTICS CHEMSTRIP 10 MD TEST STRIPS  
K983510 Urine Qualitative Dipstick Nitrite Urinalysis 06/07/2002
ROCHE DIAGNOSTICS CHEMSTRIP 10 MD TEST STRIPS  
K983510 Urine Qualitative Dipstick pH Urinalysis 06/07/2002
ROCHE DIAGNOSTICS CHEMSTRIP 10 MD TEST STRIPS  
K983510 Urine Qualitative Dipstick Protein Urinalysis 06/07/2002
ROCHE DIAGNOSTICS CHEMSTRIP 10 MD TEST STRIPS  
K983510 Urine Qualitative Dipstick Urobilinogen Urinalysis 06/07/2002
ROCHE DIAGNOSTICS CHEMSTRIP 10 MD TEST STRIPS  
K983510 Urine Qualitative Dipstick Specific Gravity Urinalysis 06/07/2002
ROCHE DIAGNOSTICS ACCU-CHEK ACTIVE SYSTEM  
K021448 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/06/2002
ROCHE DIAGNOSTICS CHOICELINE URINE 10 TEST STRIPS  
K896454 Urine Qualitative Dipstick Ketone Urinalysis 05/17/2002
ROCHE DIAGNOSTICS CHOICELINE URINE 10 TEST STRIPS  
K896454 Urine Qualitative Dipstick Bilirubin Urinalysis 05/17/2002
ROCHE DIAGNOSTICS CHOICELINE URINE 10 TEST STRIPS  
K896454 Urine Qualitative Dipstick Blood Urinalysis 05/17/2002
ROCHE DIAGNOSTICS CHOICELINE URINE 10 TEST STRIPS  
K896454 Urine Qualitative Dipstick Glucose Urinalysis 05/17/2002
ROCHE DIAGNOSTICS CHOICELINE URINE 10 TEST STRIPS  
K896454 Urine Qualitative Dipstick Leukocytes Urinalysis 05/17/2002
ROCHE DIAGNOSTICS CHOICELINE URINE 10 TEST STRIPS  
K896454 Urine Qualitative Dipstick Nitrite Urinalysis 05/17/2002
ROCHE DIAGNOSTICS CHOICELINE URINE 10 TEST STRIPS  
K896454 Urine Qualitative Dipstick pH Urinalysis 05/17/2002
ROCHE DIAGNOSTICS CHOICELINE URINE 10 TEST STRIPS  
K896454 Urine Qualitative Dipstick Protein Urinalysis 05/17/2002
ROCHE DIAGNOSTICS CHOICELINE URINE 10 TEST STRIPS  
K896454 Urine Qualitative Dipstick Urobilinogen Urinalysis 05/17/2002
ROCHE DIAGNOSTICS CHOICELINE URINE 10 TEST STRIPS  
K896454 Urine Qualitative Dipstick Specific Gravity Urinalysis 05/17/2002
ROSS PRODUCTS DIVISION FACT PLUS PRO PREGNANCY TEST  
K921170 Urine hCG By Visual Color Comparison Tests Endocrinology 03/02/2002
REMEL RIM A.R.C. HCG COMBO PREGNANCY TEST  
K932635 Urine hCG By Visual Color Comparison Tests Endocrinology 12/17/2001
ROCHE DIAGNOSTICS ACCU-CHEK ACTIVE SYSTEM  
K012324 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/17/2001
ROCHE DIAGNOSTICS ACCU-CHEK INFORM METER OTC  
K012210 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/23/2001
ROCHE DIAGNOSTICS ACCU-CHEK ACTIVE SYSTEM  
K011738 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/20/2001
ROCHE DIAGNOSTICS ACCU-CHEK ADVANTAGE {ROCHE DIAGNOSTICS ACCU-CHEK COMFORT CURVE TEST STRIP} 
K010362 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/27/2001
ROCHE DIAGNOSTICS ACCU-CHEK COMPLETE SYSTEM {ROCHE DIAGNOSTICS ACCU-CHEK COMFORT CURVE TEST STRIP} 
K010362 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/27/2001
Roche Diagnostics CoaguChek S System  
K994349 Prothrombin Time (PT) Hematology 09/06/2000
ROCHE DIAGNOSTICS CORP. ACCU-CHEK ADVANTAGE METER  
K000365 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/01/2000
ROCHE DIAGNOSTICS CORP. ACCU-CHEK COMPLETE SYSTEM  
K000364 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/01/2000
 
-
-
-
-
-