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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.

Document Test System Name
Analyte		 Analyte Specialty Effective Date
Tyson Bioresearch, Inc., Diachex+ Evolve Blood Glucose Monitoring System  
K073492 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/18/2008
Fora Care Inc. FORA D15b Blood Glucose Plus Blood Pressure Monitoring System  
K080014 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/17/2008
Fora Care Inc. FORA D15z Blood Glucose Plus Blood Pressure Monitoring System  
K080014 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/17/2008
SCI International Inc. New Choice Pro hCG Pregnancy Test 2000 mIU/mL Cassette Format  
K052694 Urine hCG By Visual Color Comparison Tests Endocrinology 12/17/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abbott ReliOn Ultima Advance Blood Glucose Monitoring System  
K081975 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/08/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K942782 Albumin General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K942782 Glucose General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K942782 Creatinine General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K942782 Urea (BUN) General Chemistry 12/04/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole blood)
K942782 Glucose General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole blood)
K942782 potassium General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole blood)
K942782 Creatinine General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole blood)
K942782 Urea (BUN) General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K950164 Calcium, Total General Chemistry 12/04/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K992140 potassium General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K992140 Carbon Dioxide, Total (CO2) General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole blood)
K992140 Creatine Kinase (CK) General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole blood)
K992140 Carbon Dioxide, Total (CO2) General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K010670 chloride General Chemistry 12/04/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole blood)
K010670 chloride General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K022312 Phosphorus General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K993211 Sodium General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole blood)
K993211 Sodium General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole blood)
K993211 Sodium General Chemistry 12/04/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K993211 Sodium General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K022312 Phosphorus General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole blood)
K010670 chloride General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K010670 chloride General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole blood)
K992140 Creatine Kinase (CK) General Chemistry 12/04/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole blood)
K992140 Carbon Dioxide, Total (CO2) General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K992140 potassium General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K992140 Carbon Dioxide, Total (CO2) General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K950164 Calcium, Total General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole blood)
K942782 Glucose General Chemistry 12/04/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole blood)
K942782 potassium General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole blood)
K942782 Creatinine General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole blood)
K942782 Urea (BUN) General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K942782 Albumin General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K942782 Glucose General Chemistry 12/04/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K942782 Creatinine General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K942782 Urea (BUN) General Chemistry 12/04/2008
Jant Pharmacal Accutest Dual Sample Immunological Fecal Occult Blood (iFOB) Test  
K073431 Fecal Occult Blood General Chemistry 12/04/2008
Jant Pharmacal Accutest Immunological Fecal Occult Blood Test (iFOBT)  
K063693 Fecal Occult Blood General Chemistry 12/04/2008
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Ketone Urinalysis 11/21/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Bilirubin Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Blood Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Glucose Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Nitrite Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick pH Urinalysis 11/21/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Protein Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Urobilinogen Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Specific Gravity Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 11SG Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Leukocytes Urinalysis 11/21/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Diagnostic Test Group Clarity Urocheck 4 OB Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Blood Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 4 OB Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Glucose Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 4 OB Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Leukocytes Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 4 OB Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Protein Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 7 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Ketone Urinalysis 11/21/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Diagnostic Test Group Clarity Urocheck 7 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Blood Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 7 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Glucose Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 7 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Leukocytes Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 7 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Nitrite Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 7 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick pH Urinalysis 11/21/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Diagnostic Test Group Clarity Urocheck 7 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Protein Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Ketone Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Blood Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Glucose Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Leukocytes Urinalysis 11/21/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Nitrite Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick pH Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Protein Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Specific Gravity Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Ketone Urinalysis 11/21/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Bilirubin Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Blood Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Glucose Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Nitrite Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick pH Urinalysis 11/21/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Protein Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Urobilinogen Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Specific Gravity Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck Blood Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Blood Urinalysis 11/21/2008
Abbott i-STAT 6+ Cartridge  (Whole blood)
K053110 Hemoglobin Hematology 11/13/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abbott i-STAT 6+ Cartridge  (Whole blood)
K053110 Glucose General Chemistry 11/13/2008
Abbott i-STAT 6+ Cartridge  (Whole blood)
K053110 Sodium General Chemistry 11/13/2008
Abbott i-STAT 6+ Cartridge  (Whole blood)
K053110 potassium General Chemistry 11/13/2008
Abbott i-STAT 6+ Cartridge  (Whole blood)
K053110 Urea (BUN) General Chemistry 11/13/2008
Abbott i-STAT 6+ Cartridge  (Whole blood)
K053110 chloride General Chemistry 11/13/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abbott i-STAT 6+ Cartridge  (Whole blood)
K053110 Hematocrit Hematology 11/13/2008
Abbott i-STAT Crea Cartridge  (Whole blood)
K053110 Creatinine General Chemistry 11/13/2008
Abbott i-STAT E3+ Cartridge  (Whole blood)
K053110 Hemoglobin Hematology 11/13/2008
Abbott i-STAT E3+ Cartridge  (Whole blood)
K053110 Sodium General Chemistry 11/13/2008
Abbott i-STAT E3+ Cartridge  (Whole blood)
K053110 potassium General Chemistry 11/13/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abbott i-STAT E3+ Cartridge  (Whole blood)
K053110 Hematocrit Hematology 11/13/2008
Abbott i-STAT EC4+ Cartridge  (Whole blood)
K053110 Hemoglobin Hematology 11/13/2008
Abbott i-STAT EC4+ Cartridge  (Whole blood)
K053110 Glucose General Chemistry 11/13/2008
Abbott i-STAT EC4+ Cartridge  (Whole blood)
K053110 Sodium General Chemistry 11/13/2008
Abbott i-STAT EC4+ Cartridge  (Whole blood)
K053110 potassium General Chemistry 11/13/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abbott i-STAT EC4+ Cartridge  (Whole blood)
K053110 Hematocrit Hematology 11/13/2008
Abbott i-STAT G Cartridge  (Whole blood)
K053110 Glucose General Chemistry 11/13/2008
Fora Care Inc. FORA D-10 Blood Glucose plus Blood Pressure Monitoring System  
K081714 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/13/2008
Nova Biomedical Nova Gold Blood Glucose Monitoring System  
K070255 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/13/2008
Siemens DCA 2000 analyzer  
K951361 Glycated Hemoglobin, Total General Chemistry 11/13/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Siemens DCA 2000+ analyzer  
K951361 Glycated Hemoglobin, Total General Chemistry 11/13/2008
Common Sense Ltd. Norma-Sense Vaginal Discharge pH Test  
X070057 pH, Urine General Chemistry 11/04/2008
IM Diagnostics, Inc. IM Maxie 2 hCG Pregnancy Urine Cassette and Dipstick Tests  
K070921 Urine hCG By Visual Color Comparison Tests Endocrinology 11/04/2008
Mossman Associates, Inc. NicCheck I Test Strips  
K963733 Nicotine And/Or Metabolites Toxicology / TDM 11/04/2008
Wako APOLOWAKO Analyzer {Whole blood} 
K080123 Glucose General Chemistry 10/31/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Wako APOLOWAKO Analyzer {Whole blood} 
K080123 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 10/31/2008
Wako APOLOWAKO Analyzer  (Whole blood)
K080125 Triglyceride General Chemistry 10/31/2008
Wako APOLOWAKO Analyzer  (Whole blood)
K080125 Cholesterol General Chemistry 10/31/2008
IM Diagnostics, Inc. IM Confirms II plus hCG Pregnancy Serum/Urine Cassette and Dipstick Tests  
K071030 Urine hCG By Visual Color Comparison Tests Endocrinology 10/28/2008
Arkray USA, Inc. GLUCOCARD 01-mini Blood Glucose Monitoring System  
K082417 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/23/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
i-SENS, Inc. CareSens II Blood Glucose Monitoring System  
K080923 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/23/2008
i-SENS, Inc. CareSens POP Blood Glucose Monitoring System  
K080923 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/23/2008
LifeScan OneTouch Vita Blood Glucose Monitoring System  
K082513 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/23/2008
Abbott Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System  
K080960 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/17/2008
Abbott Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System  
K080960 Ketone, Blood General Chemistry 10/17/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)  
K061559 Urine Qualitative Dipstick Ketone Urinalysis 10/17/2008
Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)  
K061559 Urine Qualitative Dipstick Bilirubin Urinalysis 10/17/2008
Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)  
K061559 Urine Qualitative Dipstick Blood Urinalysis 10/17/2008
Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)  
K061559 Urine Qualitative Dipstick Glucose Urinalysis 10/17/2008
Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)  
K061559 Urine Qualitative Dipstick Leukocytes Urinalysis 10/17/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)  
K061559 Urine Qualitative Dipstick Nitrite Urinalysis 10/17/2008
Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)  
K061559 Urine Qualitative Dipstick pH Urinalysis 10/17/2008
Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)  
K061559 Urine Qualitative Dipstick Protein Urinalysis 10/17/2008
Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)  
K061559 Urine Qualitative Dipstick Urobilinogen Urinalysis 10/17/2008
Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)  
K061559 Urine Qualitative Dipstick Specific Gravity Urinalysis 10/17/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)  
K061559 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 10/17/2008
Arkray USA, Inc. Assure 4 Blood Glucose Monitoring System  
K070088 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/17/2008
BTNX Rapid Response 10-SG Urinalysis Reagent Strip  
K970250 Urine Qualitative Dipstick Ketone Urinalysis 10/17/2008
BTNX Rapid Response 10-SG Urinalysis Reagent Strip  
K970250 Urine Qualitative Dipstick Bilirubin Urinalysis 10/17/2008
BTNX Rapid Response 10-SG Urinalysis Reagent Strip  
K970250 Urine Qualitative Dipstick Blood Urinalysis 10/17/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BTNX Rapid Response 10-SG Urinalysis Reagent Strip  
K970250 Urine Qualitative Dipstick Glucose Urinalysis 10/17/2008
BTNX Rapid Response 10-SG Urinalysis Reagent Strip  
K970250 Urine Qualitative Dipstick Leukocytes Urinalysis 10/17/2008
BTNX Rapid Response 10-SG Urinalysis Reagent Strip  
K970250 Urine Qualitative Dipstick Nitrite Urinalysis 10/17/2008
BTNX Rapid Response 10-SG Urinalysis Reagent Strip  
K970250 Urine Qualitative Dipstick pH Urinalysis 10/17/2008
BTNX Rapid Response 10-SG Urinalysis Reagent Strip  
K970250 Urine Qualitative Dipstick Protein Urinalysis 10/17/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BTNX Rapid Response 10-SG Urinalysis Reagent Strip  
K970250 Urine Qualitative Dipstick Urobilinogen Urinalysis 10/17/2008
BTNX Rapid Response 10-SG Urinalysis Reagent Strip  
K970250 Urine Qualitative Dipstick Specific Gravity Urinalysis 10/17/2008
Consult diagnostics Urine Analyzer  
K050801 Urine Qualitative Dipstick Ketone Urinalysis 10/17/2008
Consult diagnostics Urine Analyzer  
K050801 Urine Qualitative Dipstick Bilirubin Urinalysis 10/17/2008
Consult diagnostics Urine Analyzer  
K050801 Urine Qualitative Dipstick Blood Urinalysis 10/17/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Consult diagnostics Urine Analyzer  
K050801 Urine Qualitative Dipstick Glucose Urinalysis 10/17/2008
Consult diagnostics Urine Analyzer  
K050801 Urine Qualitative Dipstick Leukocytes Urinalysis 10/17/2008
Consult diagnostics Urine Analyzer  
K050801 Urine Qualitative Dipstick Nitrite Urinalysis 10/17/2008
Consult diagnostics Urine Analyzer  
K050801 Urine Qualitative Dipstick pH Urinalysis 10/17/2008
Consult diagnostics Urine Analyzer  
K050801 Urine Qualitative Dipstick Protein Urinalysis 10/17/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Consult diagnostics Urine Analyzer  
K050801 Urine Qualitative Dipstick Urobilinogen Urinalysis 10/17/2008
Consult diagnostics Urine Analyzer  
K050801 Urine Qualitative Dipstick Specific Gravity Urinalysis 10/17/2008
Vertex Diagnostics UltraTRAK PRO Blood Glucose Monitoring System  
K082618 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/17/2008
Bionime Corporation Rightest Blood Glucose Monitoring System, Model GM100  
K081451 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/25/2008
QUIDEL QUICKVUE DIPSTICK STREP A  (DIRECT THROAT SWAB)
K011097 Streptococcus, Group A Bacteriology 09/25/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Quidel QuickVue In-Line Strep A  (direct from throat swab)
K934484 Streptococcus, Group A Bacteriology 09/25/2008
Quidel QuickVue Influenza A+B Test  
K053146 Influenza A/B Virology 09/25/2008
Quidel QuickVue Influenza Test  
K991633 Influenza A/B Virology 09/25/2008
Quidel QuickVue RSV Test  
K061008 Respiratory Syncytial Virus Virology 09/25/2008
Quidel QuickVue RSV Test  
K070747 Respiratory Syncytial Virus Virology 09/25/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Common Sense Ltd. VA-SENSE Kit  
X070058 Vaginal pH General Chemistry 09/18/2008
EPS Bio Technology EasyPlus mini EasyMax self monitoring blood glucose system  
K082121 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/18/2008
Fora Comfort 2 in 1 TD-3250C Blood Glucose and Blood Pressure Monitoring System  
K080014 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/18/2008
Fora Comfort 2 in 1 TD-3260 Blood Glucose Plus Blood Pressure Monitoring System  
K080014 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/18/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K052719 Urine Qualitative Dipstick Ketone Urinalysis 09/18/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K052719 Urine Qualitative Dipstick Bilirubin Urinalysis 09/18/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K052719 Urine Qualitative Dipstick Blood Urinalysis 09/18/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K052719 Urine Qualitative Dipstick Glucose Urinalysis 09/18/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K052719 Urine Qualitative Dipstick Leukocytes Urinalysis 09/18/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K052719 Urine Qualitative Dipstick Nitrite Urinalysis 09/18/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K052719 Urine Qualitative Dipstick pH Urinalysis 09/18/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K052719 Urine Qualitative Dipstick Protein Urinalysis 09/18/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K052719 Urine Qualitative Dipstick Urobilinogen Urinalysis 09/18/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K052719 Urine Qualitative Dipstick Specific Gravity Urinalysis 09/18/2008
PSS World Medical QUINTET Blood Glucose Monitoring System  
K072054 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/18/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Taidoc Clever Chek TD-3250C Blood Glucose and Blood Pressure Monitoring System  
K080014 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/18/2008
Taidoc Clever Chek TD-3250D Blood Glucose and Blood Pressure Monitoring System  
K080014 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/18/2008
Bionime Corporation Rightest Blood Glucose Monitoring System, Model GM110  
K081450 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/12/2008
Andon Health Co., Ltd., andon AG-605 Blood Glucose Monitoring System  
K073030 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/04/2008
Andon Health Co., Ltd., andon AG-606 Blood Glucose Monitoring System  
K073030 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/04/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Home Diagnostics TRUEresult Blood Glucose Monitoring System  
K080641 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/20/2008
Acon Laboratories Mission UTI Urinary Tract Infection Test Strips  
K063295 Nitrite, Urine General Chemistry 08/18/2008
Acon Laboratories Mission UTI Urinary Tract Infection Test Strips  
K063295 Leukocyte Esterase, Urinary Urinalysis 08/18/2008
American Bio Medica Rapid TOX  
K053359 Amphetamines Toxicology / TDM 08/18/2008
American Bio Medica Rapid TOX  
K053359 Cannabinoids (THC) Toxicology / TDM 08/18/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
American Bio Medica Rapid TOX  
K053359 Phencyclidine (PCP) Toxicology / TDM 08/18/2008
American Bio Medica Rapid TOX  
K053359 Cocaine Metabolites Toxicology / TDM 08/18/2008
American Bio Medica Rapid TOX  
K053359 Opiates Toxicology / TDM 08/18/2008
American Bio Medica Rapid TOX  
K053359 Methadone Toxicology / TDM 08/18/2008
American Bio Medica Rapid TOX  
K053359 Propoxyphene Toxicology / TDM 08/18/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
American Bio Medica Rapid TOX  
K053359 Methamphetamines Toxicology / TDM 08/18/2008
American Bio Medica Rapid TOX  
K053359 Benzodiazepines Toxicology / TDM 08/18/2008
American Bio Medica Rapid TOX  
K053359 Barbiturates Toxicology / TDM 08/18/2008
American Bio Medica Rapid TOX  
K053359 Tricyclic Antidepressants Toxicology / TDM 08/18/2008
American Bio Medica Rapid TOX  
K053359 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 08/18/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
American Bio Medica Rapid TOX  
K053359 Oxycodone Toxicology / TDM 08/18/2008
American Bio Medica Rapid TOX  
K053359 Buprenorphine Toxicology / TDM 08/18/2008
Home Diagnostics TRUE2go Blood Glucose Monitoring System  
K080710 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/15/2008
Inverness Medical Acceava hCG Urine II  
K062361 Urine hCG By Visual Color Comparison Tests Endocrinology 08/14/2008
Home Diagnostics, Home Care Delivered TrueTrack Smart System Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/07/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Home Diagnostics, Moore Medical TrueTrack Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/07/2008
Home Diagnostics, TrueTrack for Rite Aid Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/07/2008
Home Diagnostics, TrueTrack Live Better Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/07/2008
TaiDoc Technology Corporation U-Right TD-4247 Blood Glucose Monitoring System  
K081957 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/07/2008
Aventir Biotech LLC Home Check Multiple Drug Cup Test  
K071489 Amphetamines Toxicology / TDM 07/31/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Aventir Biotech LLC Home Check Multiple Drug Cup Test  
K071489 Phencyclidine (PCP) Toxicology / TDM 07/31/2008
Aventir Biotech LLC Home Check Multiple Drug Cup Test  
K071489 Cocaine Metabolites Toxicology / TDM 07/31/2008
Aventir Biotech LLC Home Check Multiple Drug Cup Test  
K071489 Methadone Toxicology / TDM 07/31/2008
Aventir Biotech LLC Home Check Multiple Drug Cup Test  
K071489 Methamphetamines Toxicology / TDM 07/31/2008
Aventir Biotech LLC Home Check Multiple Drug Cup Test  
K071489 Benzodiazepines Toxicology / TDM 07/31/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Aventir Biotech LLC Home Check Multiple Drug Cup Test  
K071489 Barbiturates Toxicology / TDM 07/31/2008
Aventir Biotech LLC Home Check Multiple Drug Cup Test  
K071489 Morphine Toxicology / TDM 07/31/2008
Aventir Biotech LLC Home Check Multiple Drug Cup Test  
K071489 Tricyclic Antidepressants Toxicology / TDM 07/31/2008
Aventir Biotech LLC Home Check Multiple Drug Cup Test  
K071489 Oxycodone Toxicology / TDM 07/31/2008
Avnetir Biotech LLC Home Check Multiple Drug Cup Test  
K071489 Cannabinoids (THC) Toxicology / TDM 07/31/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Fora Care AudioChek Talking Mointors Blood Glucose Monitoring System Model TD-4237  
K081609 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/30/2008
Fora Care Clever Chek TD-4237 Blood Glucose Monitoring System  
K081609 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/30/2008
Fora Care Inc. FORA TD-3224 Blood Glucose Plus Blood Pressure Monitoring System  
K081714 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/30/2008
Gluco Perfect LLC, Perfect Mini Blood Glucose Monitoring System  
K052818 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/30/2008
BTNX Inc. Rapid Response Immunological Fecal Occult Blood Test (IFOBT)  
K061065 Fecal Occult Blood General Chemistry 07/22/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Healthcare Provider Direct OneStep Fecal Occult Blood (FOB) Screen Card Test  
K063693 Fecal Occult Blood General Chemistry 07/22/2008
Roche Diagnostics ACCU-CHEK Compact Plus Blood Glucose Meter  
K081389 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/22/2008
Arkray USA, Inc. GLUCOCARD 01 Blood Glucose Monitoring System  
K073416 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/17/2008
Henry Schein One Step+ Strep A Dipstick Test  
K010582 Streptococcus, Group A Bacteriology 07/17/2008
Germaine Laboratories Inc. AimStrip Urine Reagent Strips  
K051727 Urine Qualitative Dipstick Ketone Urinalysis 07/14/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Germaine Laboratories Inc. AimStrip Urine Reagent Strips  
K051727 Urine Qualitative Dipstick Glucose Urinalysis 07/14/2008
Germaine Laboratories Inc. AimStrip Urine Reagent Strips  
K051727 Urine Qualitative Dipstick Leukocytes Urinalysis 07/14/2008
Germaine Laboratories Inc. AimStrip Urine Reagent Strips  
K051727 Urine Qualitative Dipstick Nitrite Urinalysis 07/14/2008
Germaine Laboratories, Inc. AimStrip Urine Reagent Strips  
K051727 Urine Qualitative Dipstick Bilirubin Urinalysis 07/14/2008
Germaine Laboratories, Inc. AimStrip Urine Reagent Strips  
K051727 Urine Qualitative Dipstick Blood Urinalysis 07/14/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Germaine Laboratories, Inc. AimStrip Urine Reagent Strips  
K051727 Urine Qualitative Dipstick Protein Urinalysis 07/14/2008
Germaine Laboratories, Inc. AimStrip Urine Reagent Strips  
K051727 Urine Qualitative Dipstick pH Urinalysis 07/14/2008
Germaine Laboratories, Inc. AimStrip Urine Reagent Strips  
K051727 Urine Qualitative Dipstick Urobilinogen Urinalysis 07/14/2008
Germaine Laboratories, Inc. AimStrip Urine Reagent Strips  
K051727 Urine Qualitative Dipstick Specific Gravity Urinalysis 07/14/2008
Inverness Medical Acceava hCG Basic II  
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 07/14/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Inverness Medical Acceava hCG Combo II  
K062361 Urine hCG By Visual Color Comparison Tests Endocrinology 07/14/2008
BECKMAN COULTER HEMOCCULT ICT  
K080812 Fecal Occult Blood General Chemistry 07/01/2008
Germaine Laboratories Compliance Gold iFOB (immunological fecal occult blood)Test  
K063693 Fecal Occult Blood General Chemistry 07/01/2008
IDEAL LIFE Gluco-Manager GMM 0001 Blood Glucose Monitoring System  
K080283 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/30/2008
Tyson Bioresearch Inc. Diachex Basic Blood Glucose Monitoring System  
K072854 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/30/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Tyson Bioresearch Inc. Diachex Superb Blood Glucose Monitoring System  
K072854 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/30/2008
Tyson Bioresearch Inc. Diachex Vigor Blood Glucose Monitoring System  
K072854 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/30/2008
Germaine Laboratories AimStrip Pregnancy  
K974368 Urine hCG By Visual Color Comparison Tests Endocrinology 06/26/2008
AZO Test Strips Urinary Tract Infection Test  
K063295 Nitrite, Urine General Chemistry 06/25/2008
AZO Test Strips Urinary Tract Infection Test  
K063295 Leukocyte Esterase, Urinary Urinalysis 06/25/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Clever Chek Auto-Code Voice Blood Glucose Monitoring System  
K081144 Glucose General Chemistry 06/23/2008
HemoCue Albumin 201 System  
K053253 Albumin, Urinary General Chemistry 06/13/2008
SpermCheck Vasectomy  
K073039 Semen Hematology 06/12/2008