• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

CLIA - Tests waived by FDA from January 2000 to present

  • Print
  • Share
  • E-mail
-
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
Philosys Gmate SMART Blood Glucose Monitoring System  
K131230 Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/05/2014
Polymedco Poly stat H. pylori {whole blood} 
CR140223 Helicobacter pylori antibodies General Immunology 07/17/2014
Poly stat Strep A Strip Test  (Specimen Type (Throat Swab))
CR140122 Streptococcus, group A Bacteriology 05/23/2014
Polymedco Polystat Mono  (whole blood)
K961024 Infectious mononucleosis antibodies (mono) General Immunology 04/22/2014
PTox Drug Screen Cup  (Cassette Dip Card format)
K122633 Amphetamines Toxicology / TDM 04/11/2014
PTox Drug Screen Cup  (Cassette Dip Card format)
K122633 Cannabinoids (THC) Toxicology / TDM 04/11/2014
PTox Drug Screen Cup  (Cassette Dip Card format)
K122633 Phencyclidine (PCP) Toxicology / TDM 04/11/2014
PTox Drug Screen Cup  (Cassette Dip Card format)
K122633 Cocaine metabolites Toxicology / TDM 04/11/2014
PTox Drug Screen Cup  (Cassette Dip Card format)
K122633 Methadone Toxicology / TDM 04/11/2014
PTox Drug Screen Cup  (Cassette Dip Card format)
K122633 Propoxyphene Toxicology / TDM 04/11/2014
PTox Drug Screen Cup  (Cassette Dip Card format)
K122633 Methamphetamines Toxicology / TDM 04/11/2014
PTox Drug Screen Cup  (Cassette Dip Card format)
K122633 Benzodiazepines Toxicology / TDM 04/11/2014
PTox Drug Screen Cup  (Cassette Dip Card format)
K122633 Barbiturates Toxicology / TDM 04/11/2014
PTox Drug Screen Cup  (Cassette Dip Card format)
K122633 Morphine Toxicology / TDM 04/11/2014
PTox Drug Screen Cup  (Cassette Dip Card format)
K122633 Tricyclic antidepressants Toxicology / TDM 04/11/2014
PTox Drug Screen Cup  (Cassette Dip Card format)
K122633 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 04/11/2014
PTox Drug Screen Cup  (Cassette Dip Card format)
K122633 Oxycodone Toxicology / TDM 04/11/2014
PTox Drug Screen Cup  (Cassette Dip Card format)
K122633 Buprenorphine Toxicology / TDM 04/11/2014
Polymed Therapeutics Fastep s10 hcg serum/urine combo test  (Test Strip)
K132834 hCG, Urine Endocrinology 03/19/2014
Polymed Therapeutics Fastep s10 hcg serum/urine combo test  (Cassette)
K132834 hCG, Urine Endocrinology 03/19/2014
Progressive Health Supply & Source Corp. Smartest Persona II Blood Glucose Monitoring System Model 6276-S  
K133509 Glucose monitoring devices (FDA cleared/home use) General Chemistry 02/21/2014
Progressive Health Supply & Source Corp. Smartest Persona II Multi Blood Glucose Monitoring System Model 6276-M  
K133509 Glucose monitoring devices (FDA cleared/home use) General Chemistry 02/21/2014
Prodigy Choice Blood Glucose Monitoring System  
K122340 Glucose monitoring devices (FDA cleared/home use) General Chemistry 11/27/2013
Prodigy Diabetes Care, LLC Prodigy Preferred Blood Glucose Monitoring System  
K122338 Glucose monitoring devices (FDA cleared/home use) General Chemistry 11/06/2013
Poly stat Strep A Flip Test  
K040708 Streptococcus, group A Bacteriology 07/29/2013
Progressive Health Supply and Source Corp., Smartest GlucoWise Blood Glucose Monitoring System Model 6267-S  
K122525 Glucose monitoring devices (FDA cleared/home use) General Chemistry 05/02/2013
Progressive Health Supply and Source Corp., Smartest GlucoWise MULTI Blood Glucose Monitoring System Model 6267-M  
K122525 Glucose monitoring devices (FDA cleared/home use) General Chemistry 05/02/2013
Polymed Therapeutics Fastep At-Home Pregnancy Test  
K122907 Urine hCG by visual color comparison tests Endocrinology 03/25/2013
Philosys Gmate VOICE Blood Glucose Monitoring System  
K113636 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/15/2013
Premier Integrity Solutions P/Tox Drug Screen Cup  
K052115 Amphetamines Toxicology / TDM 02/08/2013
Premier Integrity Solutions P/Tox Drug Screen Cup  
K052115 Phencyclidine (PCP) Toxicology / TDM 02/08/2013
Premier Integrity Solutions P/Tox Drug Screen Cup  
K052115 Cocaine metabolites Toxicology / TDM 02/08/2013
Premier Integrity Solutions P/Tox Drug Screen Cup  
K052115 Opiates Toxicology / TDM 02/08/2013
Premier Integrity Solutions P/Tox Drug Screen Cup  
K052115 Methadone Toxicology / TDM 02/08/2013
Premier Integrity Solutions P/Tox Drug Screen Cup  
K052115 Methamphetamines Toxicology / TDM 02/08/2013
Premier Integrity Solutions P/Tox Drug Screen Cup  
K052115 Benzodiazepines Toxicology / TDM 02/08/2013
Premier Integrity Solutions P/Tox Drug Screen Cup  
K052115 Barbiturates Toxicology / TDM 02/08/2013
Premier Integrity Solutions P/Tox Drug Screen Cup  
K052115 Tricyclic antidepressants Toxicology / TDM 02/08/2013
Premier Integrity Solutions P/Tox Drug Screen Cup  
K052115 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 02/08/2013
Premier Integrity Solutions P/Tox Drug Screen Cup  
K052115 Oxycodone Toxicology / TDM 02/08/2013
Premier Integrity Solutions P/Tox Drug Screen Cup  
K052115 Cannabinoids (THC) Toxicology / TDM 02/08/2013
Pharmaceutical Marketing Systems, Inc., Thyrotest Whole Blood TSH Test  
K030912 Thyroid stimulating hormone (TSH) Endocrinology 12/11/2012
Polymed Therapeutics Fastep hCG Pregnancy Serum/Urine Combo Test  
K112101 Urine hCG by visual color comparison tests Endocrinology 07/17/2012
PSS Consult H. pylori Cassette {Whole Blood, fingerstick only} 
K024350 Helicobacter pylori antibodies General Immunology 02/03/2012
PSS World Medical, Inc., Quintet AC Blood Glucose Monitoring System  
K092052 Glucose monitoring devices (FDA cleared/home use) General Chemistry 06/22/2011
PharmTox Rapid Exam Drug Screen Test Cup  
K082898 Amphetamines Toxicology / TDM 06/17/2011
PharmTox Rapid Exam Drug Screen Test Cup  
K082898 Cannabinoids (THC) Toxicology / TDM 06/17/2011
PharmTox Rapid Exam Drug Screen Test Cup  
K082898 Phencyclidine (PCP) Toxicology / TDM 06/17/2011
PharmTox Rapid Exam Drug Screen Test Cup  
K082898 Cocaine metabolites Toxicology / TDM 06/17/2011
PharmTox Rapid Exam Drug Screen Test Cup  
K082898 Opiates Toxicology / TDM 06/17/2011
PharmTox Rapid Exam Drug Screen Test Cup  
K082898 Methadone Toxicology / TDM 06/17/2011
PharmTox Rapid Exam Drug Screen Test Cup  
K082898 Methamphetamines Toxicology / TDM 06/17/2011
PharmTox Rapid Exam Drug Screen Test Cup  
K082898 Benzodiazepines Toxicology / TDM 06/17/2011
PharmTox Rapid Exam Drug Screen Test Cup  
K082898 Barbiturates Toxicology / TDM 06/17/2011
PharmTox Rapid Exam Drug Screen Test Cup  
K082898 Tricyclic antidepressants Toxicology / TDM 06/17/2011
PharmTox Rapid Exam Drug Screen Test Cup  
K082898 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 06/17/2011
PharmTox Rapid Exam Drug Screen Test Cup  
K082898 Oxycodone Toxicology / TDM 06/17/2011
Proctor and Gamble Clearblue Plus Pregnancy Test  
K110433 Urine hCG by visual color comparison tests Endocrinology 05/13/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115 Amphetamines Toxicology / TDM 05/05/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115 Cannabinoids (THC) Toxicology / TDM 05/05/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115 Phencyclidine (PCP) Toxicology / TDM 05/05/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115 Cocaine metabolites Toxicology / TDM 05/05/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115 Opiates Toxicology / TDM 05/05/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115 Methadone Toxicology / TDM 05/05/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115 Methamphetamines Toxicology / TDM 05/05/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115 Benzodiazepines Toxicology / TDM 05/05/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115 Barbiturates Toxicology / TDM 05/05/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115 Tricyclic antidepressants Toxicology / TDM 05/05/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 05/05/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115 Oxycodone Toxicology / TDM 05/05/2011
ProAdvantage by NDC Strep A Test  
K010582 Streptococcus, group A Bacteriology 04/21/2011
PSS Consult Diagnostics Strep A Dipstick  
K023766 Streptococcus, group A Bacteriology 08/19/2010
PSS Consult Diagnostics Strep A Dipstick  
K010582 Streptococcus, group A Bacteriology 08/18/2010
Princeton BioMeditech BioSign Immunochemical Fecal Occult Blood Test (iFOBT)  
K100817 Fecal occult blood General Chemistry 07/08/2010
ProAdvantage by NDC Fecal Occult Blood Test Device  
K902360 Fecal occult blood General Chemistry 07/08/2010
Physicians' Test Multi-Drug of Abuse Urine Test  
K063545 Amphetamines Toxicology / TDM 07/04/2010
Physicians' Test Multi-Drug of Abuse Urine Test  
K063545 Cannabinoids (THC) Toxicology / TDM 07/04/2010
Physicians' Test Multi-Drug of Abuse Urine Test  
K063545 Phencyclidine (PCP) Toxicology / TDM 07/04/2010
Physicians' Test Multi-Drug of Abuse Urine Test  
K063545 Cocaine metabolites Toxicology / TDM 07/04/2010
Physicians' Test Multi-Drug of Abuse Urine Test  
K063545 Methadone Toxicology / TDM 07/04/2010
Physicians' Test Multi-Drug of Abuse Urine Test  
K063545 Methamphetamines Toxicology / TDM 07/04/2010
Physicians' Test Multi-Drug of Abuse Urine Test  
K063545 Benzodiazepines Toxicology / TDM 07/04/2010
Physicians' Test Multi-Drug of Abuse Urine Test  
K063545 Barbiturates Toxicology / TDM 07/04/2010
Physicians' Test Multi-Drug of Abuse Urine Test  
K063545 Morphine Toxicology / TDM 07/04/2010
Physicians' Test Multi-Drug of Abuse Urine Test  
K063545 Tricyclic antidepressants Toxicology / TDM 07/04/2010
Physicians' Test Multi-Drug of Abuse Urine Test  
K063545 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 07/04/2010
Progressive Health Supply and Source Corporation, Smartest Persona Blood Glucose Monitoring System  
K100701 Glucose monitoring devices (FDA cleared/home use) General Chemistry 04/15/2010
Progressive Health Supply and Source Corporation, Smartest Pronto Blood Glucose Monitoring System  
K091815 Glucose monitoring devices (FDA cleared/home use) General Chemistry 01/20/2010
Princeton BioMeditech BioSign H. pylori WB {OSOM H. pylori} ((for whole blood)
K980798 Helicobacter pylori antibodies General Immunology 11/09/2009
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
Pro-Advantage by NDC H. Pylori Device {whole blood} 
K024350 Helicobacter pylori antibodies General Immunology 08/07/2009
ProAdvantage by NDC Infectious Mononucleosis Test Device (Whole Blood Only)  
K042272 Infectious mononucleosis antibodies (mono) General Immunology 07/16/2009
PSS World Medical, Inc. Consult Diagnostics hCG Combo Cassette  
K993065 Urine hCG by visual color comparison tests Endocrinology 03/12/2009
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
PSS World Medical QUINTET Blood Glucose Monitoring System  
K072054 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/18/2008
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
PSS World Medical Select Diagnostics hCG Dipstick  
K993203 Urine hCG by visual color comparison tests Endocrinology 10/25/2007
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
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
Polymedco Poly Stat Strep A Dipstick  
K010582 Streptococcus, group A Bacteriology 09/18/2007
Polymedco, Inc. Poly stat hCG Test (Urine/Serum)  
K993065 Urine hCG by visual color comparison tests Endocrinology 08/24/2007
Physicians Medical Supply Quick Chek ultra Blood Glucose Monitoring System  
K062235 Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/09/2007
Polymedco Poly Stat H. Pylori Test {whole blood} (H. Pylori)
K024350 Helicobacter pylori antibodies General Immunology 07/25/2007
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
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
PSS World Medical Select Diagnostics Strep A Dipstick  
K010582 Streptococcus, group A Bacteriology 06/25/2007
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
PerMaxim RediScreen Strep A Twist Cassette  
K023766 Streptococcus, group A Bacteriology 05/10/2007
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 Glucose 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 Triglyceride General Chemistry 02/07/2007
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
PerMaxim RediScreen Mononucleosis  (whole blood)
K042272 Infectious mononucleosis antibodies (mono) General Immunology 07/27/2006
PFIZER CONSUMER HEALTHCARE e.p.t. Certainty 1-Step Pregnancy Test  
K061769 Urine hCG by visual color comparison tests Endocrinology 06/30/2006
Progressive Health Supply and Source Smartest Protege Blood Glucose Monitoring System  
K032029 Glucose monitoring devices (FDA cleared/home use) General Chemistry 05/22/2006
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
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
Perrigo Company +/- Pregnancy Test  
K050546 Urine hCG by visual color comparison tests Endocrinology 07/12/2005
Pfizer e.p.t Certainty Pregnancy Test  
K050930 Urine hCG by visual color comparison tests Endocrinology 05/19/2005
PerMaxim RadiScreen H. pylori Test Device  (whole blood)
K024350 Helicobacter pylori antibodies General Immunology 04/26/2005
Preferred Plus Pharmacy TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/30/2005
Polymer Technology Systems Cardiochek Brand Analyzer  
K040693 LDL cholesterol General Chemistry 03/25/2005
Polymer Technology Systems CardioChek PA Analyzer  
K040693 LDL cholesterol General Chemistry 03/25/2005
PerMaxim, RediScreen-Ultra Fecal Occult Blood Test  
K902360 Fecal occult blood General Chemistry 03/17/2005
Permaxim, LLC Rediscreen Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine qualitative dipstick ketone Urinalysis 03/02/2005
Permaxim, LLC Rediscreen Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine qualitative dipstick bilirubin Urinalysis 03/02/2005
Permaxim, LLC Rediscreen Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine qualitative dipstick blood Urinalysis 03/02/2005
Permaxim, LLC Rediscreen Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine qualitative dipstick glucose Urinalysis 03/02/2005
Permaxim, LLC Rediscreen Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine qualitative dipstick leukocytes Urinalysis 03/02/2005
Permaxim, LLC Rediscreen Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine qualitative dipstick nitrite Urinalysis 03/02/2005
Permaxim, LLC Rediscreen Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine qualitative dipstick Ph Urinalysis 03/02/2005
Permaxim, LLC Rediscreen Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine qualitative dipstick protein Urinalysis 03/02/2005
Permaxim, LLC Rediscreen Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine qualitative dipstick urobilinogen Urinalysis 03/02/2005
Permaxim, LLC Rediscreen Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine qualitative dipstick specific gravity Urinalysis 03/02/2005
Permaxim, LLC Rediscreen Urinalysis Reagent Strips  (Manual - Qualitative)
K040703 Urine qualitative dipstick ascorbic acid Urinalysis 03/02/2005
Physician Sales & Services, Inc. PSS Select Urine Analyzer  
K980047 Urine qualitative dipstick ketone Urinalysis 02/18/2005
Physician Sales & Services, Inc. PSS Select Urine Analyzer  
K980047 Urine qualitative dipstick bilirubin Urinalysis 02/18/2005
Physician Sales & Services, Inc. PSS Select Urine Analyzer  
K980047 Urine qualitative dipstick blood Urinalysis 02/18/2005
Physician Sales & Services, Inc. PSS Select Urine Analyzer  
K980047 Urine qualitative dipstick glucose Urinalysis 02/18/2005
Physician Sales & Services, Inc. PSS Select Urine Analyzer  
K980047 Urine qualitative dipstick leukocytes Urinalysis 02/18/2005
Physician Sales & Services, Inc. PSS Select Urine Analyzer  
K980047 Urine qualitative dipstick nitrite Urinalysis 02/18/2005
Physician Sales & Services, Inc. PSS Select Urine Analyzer  
K980047 Urine qualitative dipstick Ph Urinalysis 02/18/2005
Physician Sales & Services, Inc. PSS Select Urine Analyzer  
K980047 Urine qualitative dipstick protein Urinalysis 02/18/2005
Physician Sales & Services, Inc. PSS Select Urine Analyzer  
K980047 Urine qualitative dipstick urobilinogen Urinalysis 02/18/2005
Physician Sales & Services, Inc. PSS Select Urine Analyzer  
K980047 Urine qualitative dipstick specific gravity Urinalysis 02/18/2005
PHAMATECH QUICKSCREEN (MODEL 9177X)  
K041578 Amphetamines Toxicology / TDM 02/15/2005
PHAMATECH QUICKSCREEN (MODEL 9177X)  
K041578 Cannabinoids (THC) Toxicology / TDM 02/15/2005
PHAMATECH QUICKSCREEN (MODEL 9177X)  
K041578 Phencyclidine (PCP) Toxicology / TDM 02/15/2005
PHAMATECH QUICKSCREEN (MODEL 9177X)  
K041578 Cocaine metabolites Toxicology / TDM 02/15/2005
PHAMATECH QUICKSCREEN (MODEL 9177X)  
K041578 Opiates Toxicology / TDM 02/15/2005
PHAMATECH QUICKSCREEN (MODEL 9178X)  
K041578 Amphetamines Toxicology / TDM 02/15/2005
PHAMATECH QUICKSCREEN (MODEL 9178X)  
K041578 Cannabinoids (THC) Toxicology / TDM 02/15/2005
PHAMATECH QUICKSCREEN (MODEL 9178X)  
K041578 Cocaine metabolites Toxicology / TDM 02/15/2005
PHAMATECH QUICKSCREEN (MODEL 9178X)  
K041578 Opiates Toxicology / TDM 02/15/2005
PHAMATECH QUICKSCREEN (MODEL 9178X)  
K041578 Methamphetamines Toxicology / TDM 02/15/2005
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER PLUS {PTS PANELS CHOL+GLU TEST PANEL} 
K041750 Glucose monitoring devices (FDA cleared/home use) General Chemistry 02/15/2005
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER PLUS {PTS PANELS CHOL+GLU TEST PANEL} 
K041750 Cholesterol General Chemistry 02/15/2005
Polymer Technology Systems CardioChek Analyzer {PTS PANELS CHOL+GLU TEST PANEL} 
K041750 Glucose monitoring devices (FDA cleared/home use) General Chemistry 02/15/2005
Polymer Technology Systems CardioChek Analyzer {PTS PANELS CHOL+GLU TEST PANEL} 
K041750 Cholesterol General Chemistry 02/15/2005
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS CHOL+GLU TEST PANEL} 
K041750 Cholesterol General Chemistry 02/15/2005
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS CHOL+GLU TEST PANEL} (Professional Use)
K041750 Glucose General Chemistry 02/15/2005
PRINCETON BIOMEDITECH STATUS FIRST STREP A  
K040708 Streptococcus, group A Bacteriology 01/19/2005
PROVALIS DIAGNOSTICS IN2IT IN-OFFICE ANALYZER (II) A1C PRESCRIPTION HOME USE TEST SYSTEM  
K041635 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 11/09/2004
PEP PERFORMANCE ENHANCED PRODUCTS STREP A CASSETTE TEST  
K023766 Streptococcus, group A Bacteriology 09/16/2004
PEP PERFORMANCE ENHANCED PRODUCTS STREP A DIPSTICK  
K010582 Streptococcus, group A Bacteriology 09/16/2004
POLYMEDCO POLY STAT OC-LIGHT FOB TEST  
K041297 Fecal occult blood General Chemistry 08/18/2004
PROVALIS DIAGNOSTICS G5 II HBA1C TEST SYSTEM  
K041635 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 08/18/2004
POLYMEDCO POLY STAT STREP A LIQUID TEST  
K021375 Streptococcus, group A Bacteriology 06/04/2004
PHAMATECH MOMENTS MENOPAUSE CHECK  
K040575 Follicle stimulating hormone (FSH) Endocrinology 05/26/2004
PFIZER CONSUMER HEALTHCARE E.P.T. PREGNANCY TEST  
K040329 Urine hCG by visual color comparison tests Endocrinology 03/08/2004
PFIZER CONSUMER HEALTHCARE E.P.T. PREGNANCY TEST  
K033658 Urine hCG by visual color comparison tests Endocrinology 01/20/2004
PERMAXIM REDISCREEN URINALYSIS REAGENT STRIPS 10 PARAMETERS  
K991927 Urine qualitative dipstick ketone Urinalysis 12/17/2003
PERMAXIM REDISCREEN URINALYSIS REAGENT STRIPS 10 PARAMETERS  
K991927 Urine qualitative dipstick bilirubin Urinalysis 12/17/2003
PERMAXIM REDISCREEN URINALYSIS REAGENT STRIPS 10 PARAMETERS  
K991927 Urine qualitative dipstick blood Urinalysis 12/17/2003
PERMAXIM REDISCREEN URINALYSIS REAGENT STRIPS 10 PARAMETERS  
K991927 Urine qualitative dipstick glucose Urinalysis 12/17/2003
PERMAXIM REDISCREEN URINALYSIS REAGENT STRIPS 10 PARAMETERS  
K991927 Urine qualitative dipstick leukocytes Urinalysis 12/17/2003
PERMAXIM REDISCREEN URINALYSIS REAGENT STRIPS 10 PARAMETERS  
K991927 Urine qualitative dipstick nitrite Urinalysis 12/17/2003
PERMAXIM REDISCREEN URINALYSIS REAGENT STRIPS 10 PARAMETERS  
K991927 Urine qualitative dipstick Ph Urinalysis 12/17/2003
PERMAXIM REDISCREEN URINALYSIS REAGENT STRIPS 10 PARAMETERS  
K991927 Urine qualitative dipstick protein Urinalysis 12/17/2003
PERMAXIM REDISCREEN URINALYSIS REAGENT STRIPS 10 PARAMETERS  
K991927 Urine qualitative dipstick urobilinogen Urinalysis 12/17/2003
PERMAXIM REDISCREEN URINALYSIS REAGENT STRIPS 10 PARAMETERS  
K991927 Urine qualitative dipstick specific gravity Urinalysis 12/17/2003
PAN PROBE BIOTECH EARLYDETECT MENOPAUSE TEST FOR FSH  
K030058 Follicle stimulating hormone (FSH) Endocrinology 07/31/2003
PERMAXIM REDISCREEN MIDSTREAM URINE OVULATION TEST  
K012252 Ovulation test (LH) By visual color comparison Endocrinology 07/11/2003
PERMAXIM REDISCREEN MIDSTREAM URINE PREGNANCY TEST  
K983090 Urine hCG by visual color comparison tests Endocrinology 07/11/2003
PERMAXIM REDISCREEN PREGNANCY TEST STRIP (URINE)  
K993203 Urine hCG by visual color comparison tests Endocrinology 07/11/2003
PERMAXIM REDISCREEN URINE PREGNANCY CASSETTE DEVICE  
K993317 Urine hCG by visual color comparison tests Endocrinology 07/11/2003
PERMAXIM REDISCREEN STREP A RAPID TEST  
K010582 Streptococcus, group A Bacteriology 07/08/2003
PHAMATECH AT HOME DRUG TEST (MODEL 9150X)  
K030447 Amphetamines Toxicology / TDM 05/01/2003
PHAMATECH AT HOME DRUG TEST (MODEL 9150X)  
K030447 Cannabinoids (THC) Toxicology / TDM 05/01/2003
PHAMATECH AT HOME DRUG TEST (MODEL 9150X)  
K030447 Cocaine metabolites Toxicology / TDM 05/01/2003
PHAMATECH AT HOME DRUG TEST (MODEL 9150X)  
K030447 Opiates Toxicology / TDM 05/01/2003
PHAMATECH AT HOME DRUG TEST (MODEL 9150X)  
K030447 Methamphetamine/amphetamine Toxicology / TDM 05/01/2003
PHAMATECH AT HOME QUICK CUP PREGNANCY TEST  
K993141 Urine hCG by visual color comparison tests Endocrinology 12/09/2002
PHAMATECH CLEAR CHOICE PREGNANCY TEST  
K993141 Urine hCG by visual color comparison tests Endocrinology 12/09/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER PLUS {PTS PANELS LIPID PANEL TEST STRIPS} 
K023558 Triglyceride General Chemistry 11/21/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER PLUS {PTS PANELS LIPID PANEL TEST STRIPS} 
K023558 HDL cholesterol General Chemistry 11/21/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER PLUS {PTS PANELS LIPID PANEL TEST STRIPS} 
K023558 Cholesterol General Chemistry 11/21/2002
Polymer Technology Systems CardioChek Analyzer {PTS PANELS LIPID PANEL TEST STRIPS} 
K023558 Triglyceride General Chemistry 11/21/2002
Polymer Technology Systems CardioChek Analyzer {PTS PANELS LIPID PANEL TEST STRIPS} 
K023558 HDL cholesterol General Chemistry 11/21/2002
Polymer Technology Systems CardioChek Analyzer {PTS PANELS LIPID PANEL TEST STRIPS} 
K023558 Cholesterol General Chemistry 11/21/2002
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS LIPID PANEL TEST STRIPS} 
K023558 Triglyceride General Chemistry 11/21/2002
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS LIPID PANEL TEST STRIPS} 
K023558 HDL cholesterol General Chemistry 11/21/2002
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS LIPID PANEL TEST STRIPS} 
K023558 Cholesterol General Chemistry 11/21/2002
PHAMATECH OVUCARD LH TEST  (Cassette)
K990249 Ovulation test (LH) By visual color comparison Endocrinology 11/20/2002
PHAMATECH OVUSTICK LH TEST  (strip)
K990249 Ovulation test (LH) By visual color comparison Endocrinology 11/20/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER PLUS {PTS PANELS LIPID PANEL TEST STRIPS} 
K022898 Triglyceride General Chemistry 10/18/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER PLUS {PTS PANELS LIPID PANEL TEST STRIPS} 
K022898 HDL cholesterol General Chemistry 10/18/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER PLUS {PTS PANELS LIPID PANEL TEST STRIPS} 
K022898 Cholesterol General Chemistry 10/18/2002
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS LIPID PANEL TEST STRIPS} 
K022898 Triglyceride General Chemistry 10/18/2002
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS LIPID PANEL TEST STRIPS} 
K022898 HDL cholesterol General Chemistry 10/18/2002
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS LIPID PANEL TEST STRIPS} 
K022898 Cholesterol General Chemistry 10/18/2002
PHAMATECH ONE-STEP OPIATE DRUG SCREENING TEST {Cassette} 
K972619 Opiates Toxicology / TDM 09/20/2002
PHAMATECH QUICKSCREEN ONE-STEP OPIATE {DIP} 
K972619 Opiates Toxicology / TDM 09/20/2002
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9177)  
K993165 Amphetamines Toxicology / TDM 08/29/2002
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9177)  
K993165 Cannabinoids (THC) Toxicology / TDM 08/29/2002
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9177)  
K993165 Phencyclidine (PCP) Toxicology / TDM 08/29/2002
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9177)  
K993165 Cocaine metabolites Toxicology / TDM 08/29/2002
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9177)  
K993165 Opiates Toxicology / TDM 08/29/2002
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9177)  
K993165 Methamphetamines Toxicology / TDM 08/29/2002
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9178)  
K993165 Amphetamines Toxicology / TDM 08/29/2002
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9178)  
K993165 Cannabinoids (THC) Toxicology / TDM 08/29/2002
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9178)  
K993165 Phencyclidine (PCP) Toxicology / TDM 08/29/2002
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9178)  
K993165 Cocaine metabolites Toxicology / TDM 08/29/2002
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9178)  
K993165 Opiates Toxicology / TDM 08/29/2002
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9178)  
K993165 Methamphetamines Toxicology / TDM 08/29/2002
PHAMATECH QUICKSCREEN PCP DRUG SCREENING TEST  (DIP)
K974582 Phencyclidine (PCP) Toxicology / TDM 08/26/2002
PHAMATECH QUICKSCREEN PCP DRUG SCREENING TEST  (Cassette)
K974582 Phencyclidine (PCP) Toxicology / TDM 08/26/2002
PHAMATECH QUICK SCREEN THC DRUG SCREENING TEST  (Cassette)
K973122 Cannabinoids (THC) Toxicology / TDM 08/23/2002
PHAMATECH QUICK SCREEN THC DRUG SCREENING TEST  (DIP)
K973122 Cannabinoids (THC) Toxicology / TDM 08/23/2002
PHAMATECH QUICKSCREEN AMPHETAMINE DRUG SCREENING TEST  (Cassette)
K972577 Amphetamines Toxicology / TDM 08/23/2002
PHAMATECH QUICKSCREEN AMPHETAMINE DRUG SCREENING TEST  (DIP)
K972577 Amphetamines Toxicology / TDM 08/23/2002
PHAMATECH QUICKSCREEN COCAINE DRUG SCREENING TEST  (Cassette)
K972618 Cocaine metabolites Toxicology / TDM 08/23/2002
PHAMATECH QUICKSCREEN COCAINE DRUG SCREENING TEST  (DIP)
K972618 Cocaine metabolites Toxicology / TDM 08/23/2002
PHAMATECH QUICKSCREEN METHAMPHETAMINE DRUG SCREEN TEST  (Cassette)
K972556 Methamphetamines Toxicology / TDM 08/23/2002
PHAMATECH QUICKSCREEN METHAMPHETAMINE DRUG SCREEN TEST  (DIP)
K972556 Methamphetamines Toxicology / TDM 08/23/2002
PAN PROBE BIOTECH LIVESURE HCG URINARY PREGNANCY TEST CARD  
K020968 Urine hCG by visual color comparison tests Endocrinology 07/15/2002
PAN PROBE BIOTECH LIVESURE HCG URINARY PREGNANCY TEST STRIP  
K020968 Urine hCG by visual color comparison tests Endocrinology 07/15/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER 2000 PTS PANELS  
K990688 Cholesterol General Chemistry 06/25/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER 2000 PTS PANELS  
K981493 Cholesterol General Chemistry 06/25/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER 2000 PTS PANELS  
K993377 HDL cholesterol General Chemistry 06/25/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER 2000 PTS PANELS  
K990247 HDL cholesterol General Chemistry 06/25/2002
Polymer Technology Systems CardioChek Analyzer  
K014099 Glucose monitoring devices (FDA cleared/home use) General Chemistry 06/25/2002
Polymer Technology Systems CardioChek PA Analyzer  
K014099 Glucose monitoring devices (FDA cleared/home use) General Chemistry 06/25/2002
POLYMER TECHNOLOGY SYSTEMS PTS GLUCOSE Q3  
K014099 Glucose monitoring devices (FDA cleared/home use) General Chemistry 06/25/2002
POLYMER TECHNOLOGY SYSTEMS PTS PANELS GLUCOSE TEST STRIPS  
K014099 Glucose monitoring devices (FDA cleared/home use) General Chemistry 06/25/2002
PRINCETON BIOMEDITECH ACCUSIGN COC  
K014069 Cocaine metabolites Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN DOA 4 (THC/OPI/COC/MET)  
K014193 Cannabinoids (THC) Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN DOA 4 (THC/OPI/COC/MET)  
K014193 Cocaine metabolites Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN DOA 4 (THC/OPI/COC/MET)  
K014193 Opiates Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN DOA 4 (THC/OPI/COC/MET)  
K014193 Methamphetamines Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN STIK COC  
K014069 Cocaine metabolites Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN STIK MET  
K014192 Methamphetamines Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN STIK THC  
K014066 Cannabinoids (THC) Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN STIK THC/OPI/COC/MET  
K014193 Cannabinoids (THC) Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN STIK THC/OPI/COC/MET  
K014193 Cocaine metabolites Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN STIK THC/OPI/COC/MET  
K014193 Opiates Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN STIK THC/OPI/COC/MET  
K014193 Methamphetamines Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN THC  
K014066 Cannabinoids (THC) Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSTIK COC  
K014069 Cocaine metabolites Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSTIK DOA4  
K014193 Cannabinoids (THC) Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSTIK DOA4  
K014193 Cocaine metabolites Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSTIK DOA4  
K014193 Opiates Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSTIK DOA4  
K014193 Methamphetamines Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSTIK MET  
K014192 Methamphetamines Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSTIK THC  
K014066 Cannabinoids (THC) Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSTRIP COC  
K014069 Cocaine metabolites Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSTRIP DOA4 (THC/OPI/COC/MET)  
K014193 Cannabinoids (THC) Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSTRIP DOA4 (THC/OPI/COC/MET)  
K014193 Cocaine metabolites Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSTRIP DOA4 (THC/OPI/COC/MET)  
K014193 Opiates Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSTRIP DOA4 (THC/OPI/COC/MET)  
K014193 Methamphetamines Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSTRIP MET  
K014192 Methamphetamines Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSTRIP THC  
K014066 Cannabinoids (THC) Toxicology / TDM 06/07/2002
Princeton BioMeditech LifeSign Home Drug Test (MET)  
K014192 Methamphetamines Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH LIFESIGN HOME DRUG TEST (THC/OPI/COC/MET)  
K014193 Cannabinoids (THC) Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH LIFESIGN HOME DRUG TEST (THC/OPI/COC/MET)  
K014193 Cocaine metabolites Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH LIFESIGN HOME DRUG TEST (THC/OPI/COC/MET)  
K014193 Opiates Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH LIFESIGN HOME DRUG TEST (THC/OPI/COC/MET)  
K014193 Methamphetamines Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH LIFESIGN HOME DRUG TEST COCAINE  
K014069 Cocaine metabolites Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH LIFESIGN HOME DRUG TEST MARIJUANA  
K014066 Cannabinoids (THC) Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH STATUS DS COC  
K014069 Cocaine metabolites Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH STATUS DS DOA4 (THC/OPI/COC/MET)  
K014193 Cannabinoids (THC) Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH STATUS DS DOA4 (THC/OPI/COC/MET)  
K014193 Cocaine metabolites Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH STATUS DS DOA4 (THC/OPI/COC/MET)  
K014193 Opiates Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH STATUS DS DOA4 (THC/OPI/COC/MET)  
K014193 Methamphetamines Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH STATUS DS MET  
K014192 Methamphetamines Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH STATUS DS THC  
K014066 Cannabinoids (THC) Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH STATUS STIK COC  
K014069 Cocaine metabolites Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH STATUS STIK MET  
K014192 Methamphetamines Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH STATUS STIK THC  
K014066 Cannabinoids (THC) Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH STATUS STIK THC/OPI/COC/MET  
K014193 Cannabinoids (THC) Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH STATUS STIK THC/OPI/COC/MET  
K014193 Cocaine metabolites Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH STATUS STIK THC/OPI/COC/MET  
K014193 Opiates Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH STATUS STIK THC/OPI/COC/MET  
K014193 Methamphetamines Toxicology / TDM 06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN STIK THC/COC  
K014067 Cannabinoids (THC) Toxicology / TDM 06/06/2002
PRINCETON BIOMEDITECH ACCUSIGN STIK THC/COC  
K014067 Cocaine metabolites Toxicology / TDM 06/06/2002
PRINCETON BIOMEDITECH ACCUSIGN THC/COC  
K014067 Cannabinoids (THC) Toxicology / TDM 06/06/2002
PRINCETON BIOMEDITECH ACCUSIGN THC/COC  
K014067 Cocaine metabolites Toxicology / TDM 06/06/2002
PRINCETON BIOMEDITECH ACCUSTIK THC/COC  
K014067 Cannabinoids (THC) Toxicology / TDM 06/06/2002
PRINCETON BIOMEDITECH ACCUSTIK THC/COC  
K014067 Cocaine metabolites Toxicology / TDM 06/06/2002
PRINCETON BIOMEDITECH ACCUSTRIP THC/COC  
K014067 Cannabinoids (THC) Toxicology / TDM 06/06/2002
PRINCETON BIOMEDITECH ACCUSTRIP THC/COC  
K014067 Cocaine metabolites Toxicology / TDM 06/06/2002
PRINCETON BIOMEDITECH LIFESIGN HOME DRUG TEST (THC/COC)  
K014067 Cannabinoids (THC) Toxicology / TDM 06/06/2002
PRINCETON BIOMEDITECH LIFESIGN HOME DRUG TEST (THC/COC)  
K014067 Cocaine metabolites Toxicology / TDM 06/06/2002
PRINCETON BIOMEDITECH STATUS DS THC/COC  
K014067 Cannabinoids (THC) Toxicology / TDM 06/06/2002
PRINCETON BIOMEDITECH STATUS DS THC/COC  
K014067 Cocaine metabolites Toxicology / TDM 06/06/2002
PRINCETON BIOMEDITECH STATUS STIK THC/COC  
K014067 Cannabinoids (THC) Toxicology / TDM 06/06/2002
PRINCETON BIOMEDITECH STATUS STIK THC/COC  
K014067 Cocaine metabolites Toxicology / TDM 06/06/2002
PRINCETON BIOMEDITECH BIOSIGN HCG SERUM/URINE  
K020439 Urine hCG by visual color comparison tests Endocrinology 05/23/2002
PRINCETON BIOMEDITECH STATUS HCG SERUM/URINE  
K020439 Urine hCG by visual color comparison tests Endocrinology 05/23/2002
PSS SELECT REAGENT STRIPS FOR URINALYSIS  
K981555 Urine dipstick or tablet analytes, nonautomated Urinalysis 05/17/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER 2000 PTS PANELS GLUCOSE TEST STRIPS  
K013068 Glucose monitoring devices (FDA cleared/home use) General Chemistry 05/10/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER 2000 PTS PANELS GLUCOSE TEST STRIPS  
K972669 Glucose monitoring devices (FDA cleared/home use) General Chemistry 05/10/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER 2000 PTS PANELS KETONE TEST STRIPS  
K983860 Ketone, blood General Chemistry 05/10/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER 2000 PTS PANELS KETONE TEST STRIPS  
K981865 Ketone, blood General Chemistry 05/10/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER 2000 PTS PANELS TRIGLYCERIDES TEST STRIPS  (For OTC use)
K000586 Triglyceride General Chemistry 04/30/2002
POLYMEDICA PHARMACEUTICALS, U.S.A. LIBERTY BLOOD GLUCOSE MONITORING SYSTEM  
K014167 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/14/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER PLUS PROFESSIONAL AND OTC  
K014099 Glucose monitoring devices (FDA cleared/home use) General Chemistry 12/21/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9064)  
K013410 Amphetamines Toxicology / TDM 12/17/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9069)  
K013412 Methamphetamines Toxicology / TDM 12/17/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9074)  
K013409 Cocaine metabolites Toxicology / TDM 12/17/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9079)  
K013408 Cannabinoids (THC) Toxicology / TDM 12/17/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9084)  
K013407 Opiates Toxicology / TDM 12/17/2001
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER  
K013068 Glucose monitoring devices (FDA cleared/home use) General Chemistry 12/17/2001
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER BEYOND  
K013203 Glucose monitoring devices (FDA cleared/home use) General Chemistry 11/13/2001
PROVALIS DIAGNOSTICS GLYCOSAL II HBA1C  
K011933 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 11/09/2001
PSS SELECT OCCULT BLOOD TEST  
K911075 Fecal occult blood General Chemistry 09/27/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9078T)  
K010654 Cannabinoids (THC) Toxicology / TDM 07/27/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9068T)  
K010653 Methamphetamines Toxicology / TDM 07/20/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9063 T)  
K010645 Amphetamines Toxicology / TDM 04/23/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9073 T)  
K010650 Cocaine metabolites Toxicology / TDM 04/23/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9083 T)  
K010646 Opiates Toxicology / TDM 04/23/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9133 T)  
K010651 Phencyclidine (PCP) Toxicology / TDM 04/23/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9150T)  
K010655 Amphetamines Toxicology / TDM 04/04/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9150T)  
K010655 Cannabinoids (THC) Toxicology / TDM 04/04/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9150T)  
K010655 Cocaine metabolites Toxicology / TDM 04/04/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9150T)  
K010655 Opiates Toxicology / TDM 04/04/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9150T)  
K010655 Methamphetamine/amphetamine Toxicology / TDM 04/04/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9068)  
K003858 Methamphetamines Toxicology / TDM 02/27/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9150)  
K003858 Amphetamines Toxicology / TDM 02/27/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9150)  
K003858 Cannabinoids (THC) Toxicology / TDM 02/27/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9150)  
K003858 Cocaine metabolites Toxicology / TDM 02/27/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9150)  
K003858 Opiates Toxicology / TDM 02/27/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9150)  
K003858 Methamphetamines Toxicology / TDM 02/27/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9175)  
K003858 Cannabinoids (THC) Toxicology / TDM 02/27/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9175)  
K003858 Opiates Toxicology / TDM 02/27/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9175)  
K003858 Methamphetamines Toxicology / TDM 02/27/2001
POLYMER TECHNOLOGY SYSTEMS, BIOSCANNER  (For OTC use)
K000586 Triglyceride General Chemistry 06/29/2000
PRINCETON BIOMEDITECH BIOSTREP A  
K983386 Streptococcus, group A Bacteriology 05/17/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9063)  
K994237 Amphetamines Toxicology / TDM 04/19/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9068)  
K994233 Methamphetamines Toxicology / TDM 04/19/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9073)  
K994219 Cocaine metabolites Toxicology / TDM 04/19/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9078)  
K994220 Cannabinoids (THC) Toxicology / TDM 04/19/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9083)  
K994234 Opiates Toxicology / TDM 04/19/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9133)  
K994236 Phencyclidine (PCP) Toxicology / TDM 04/19/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9170)  
K991641 Cannabinoids (THC) Toxicology / TDM 04/19/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9170)  
K991641 Cocaine metabolites Toxicology / TDM 04/19/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9171)  
K991824 Opiates Toxicology / TDM 04/19/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9171)  
K991824 Methamphetamines Toxicology / TDM 04/19/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9175)  
K992217 Cannabinoids (THC) Toxicology / TDM 04/19/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9175)  
K992217 Opiates Toxicology / TDM 04/19/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9175)  
K992217 Methamphetamines Toxicology / TDM 04/19/2000
PHAMATECH QUICKSCREEN AT HOME DRUG TEST MODEL 9149/9150  
K982621 Amphetamines Toxicology / TDM 04/19/2000
PHAMATECH QUICKSCREEN AT HOME DRUG TEST MODEL 9149/9150  
K982621 Phencyclidine (PCP) Toxicology / TDM 04/19/2000
PHAMATECH QUICKSCREEN AT HOME DRUG TEST MODEL 9149/9150  
K982621 Cocaine metabolites Toxicology / TDM 04/19/2000
PHAMATECH QUICKSCREEN AT HOME DRUG TEST MODEL 9149/9150  
K982621 Opiates Toxicology / TDM 04/19/2000
PHAMATECH QUICKSCREEN AT HOME DRUG TEST MODEL 9149/9150  
K982621 Methamphetamines Toxicology / TDM 04/19/2000
POLYMEDCO POLY STAT A (II)  
K973111 Streptococcus, group A Bacteriology 04/13/2000
POLYMER TECHNOLOGY SYSTEMS, BIOSCANNER TEST STRIPS CHOLESTEROL  (For Professional Use)
K990247 Cholesterol General Chemistry 04/03/2000
POLYMEDCO POLY STAT HCG  
K932635 Urine hCG by visual color comparison tests Endocrinology 02/25/2000
Polymedco Polystat Mono  
K973559 Infectious mononucleosis antibodies (mono) General Immunology 02/14/2000
-
-