meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
57
Latest Decision
1997-08-01

Clearances · page 43 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K972682 QUICKSTICK ONE STEP HCG PREGNANCY TEST Phamatech LCX Class II 1997-08-01
K971309 UREA Derma Media Lab., Inc. CDQ Class II 1997-08-01
K972024 CODA AUTOMATED EIA ANALYZER Bio-Rad JJI Class I 1997-07-30
K972687 CARDIAC STATUS CONTROLS/TROPONIN I Spectral Diagnostics, Inc. JJX Class I 1997-07-28
K972408 CARDIAC STATUS CONTROLS Spectral Diagnostics, Inc. JJT Class I 1997-07-25
K971792 IMMULITE FREE T4 (2-STEP) Diagnostic Products Corp. CEC Class II 1997-07-25
K964590 COLORMATE III Chromatics Color Sciences Intl., Inc. MQM Class I 1997-07-24
K971825 PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST Randox Laboratories, Ltd. JFJ Class II 1997-07-24
K972012 CHOLESTECH BUN/CREATININE TEST SYSTEM Cholestech Corp. CDN Class II 1997-07-24
K972094 TARGET CARDIAC TROPONIN I TEST Texas Immunology, Inc. MMI Class II 1997-07-23
K972333 AMMONIA/IRON STANDARD KIT Verichem Laboratories, Inc. JIX Class II 1997-07-23
K972041 EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5) Sigma Diagnostics, Inc. LBS Class I 1997-07-22
K971761 PERSONALLAB AUTOMATED MICROPLATE ANALYZER Biochem Immunosystems (U.S.), Inc. JJE Class I 1997-07-22
K971754 LIQUID GLUCOSE (HEXOKINASE) REAGENT SET Pointe Scientific, Inc., CFR Class II 1997-07-22
K972671 BUN (LIQUID) REAGENT SET Pointe Scientific, Inc., CDQ Class II 1997-07-20
K972155 CREATINE KINASE (CK) Stanbio Laboratory CGS Class II 1997-07-17
K972297 AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) Trace America, Inc. JFJ Class II 1997-07-17
K971566 CREATINE KINASE-MB REAGENT SET Horizon Diagnostics, Inc. CGS Class II 1997-07-14
K972287 DADE TRU-LIQUID BILIRUBIN CONTROL Dade Intl., Inc. JJX Class I 1997-07-07
K970420 MASTERCAP AM 5.0/MASTERCAP RM 5.0 Pharmacia, Inc. JQW Class I 1997-06-30
K971103 AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM Tosoh Medics, Inc. KHO Class I 1997-06-27
K972070 NICHOLS ADVANTAGE CHEMILUMINESCENCE TRI-LEVEL SPECIALTY CONTROLS Nichols Institute Diagnostics JJY Class I 1997-06-26
K971491 SYNERMED IR 200 CHEMISTRY ANALYZER Synermed, Inc. JJF Class I 1997-06-26
K972232 ABBOTT AXSYM FOLATE Abbott Laboratories CGN Class II 1997-06-24
K971921 PROLACTIN (PRL) HORMONE MICROPLATE ELISA Monobind CFT Class I 1997-06-24
K972133 VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070) Johnson & Johnson Clinical Diagnostics, Inc. JLS Class I 1997-06-24
K972214 ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN) Roche Diagnostic Systems, Inc. JJY Class I 1997-06-24
K972073 TOTAL BILIRUBIN REAGENT Carolina Liquid Chemistries Corp. CIG Class II 1997-06-24
K971780 THYROTROPIN(TSH) ELISA Monobind JLW Class II 1997-06-24
K971907 CALCIUM REAGENT Carolina Liquid Chemistries Corp. CIC Class II 1997-06-24
K971324 TRIGLYCERIDES, TG, OR TRIG Carolina Liquid Chemistries Corp. CDT Class I 1997-06-20
K970707 ELECT II BLOOD GLUCOSE MONITORING SYSTEM Selfcare, Inc. CGA Class II 1997-06-20
K971072 CHOLESTEROL REAGENT Derma Media Lab., Inc. CHH Class I 1997-06-20
K971725 OPUS PROGESTERONE Behring Diagnostics, Inc. JLS Class I 1997-06-18
K971573 N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET Genzyme Corp. LBR Class I 1997-06-18
K972080 QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND CONTROL LEVELS 1, 2 AND 3 Consolidated Technologies, Inc. JJY Class I 1997-06-18
K971967 BUN Carolina Liquid Chemistries Corp. CDQ Class II 1997-06-17
K971908 CREA OR CREATININE Carolina Liquid Chemistries Corp. CGX Class II 1997-06-17
K971449 VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE) Becton Dickinson Vacutainer Systems GIM Class II 1997-06-17
K971405 SPECIALITY URINE 1,2 Chiron Diagnostics Corp. JJY Class I 1997-06-16
K971467 SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU) Carolina Liquid Chemistries Corp. CFR Class II 1997-06-16
K971823 ACTIVE TESTOSTERONE EIA (DSL-10-4000) Diagnostic Systems Laboratories, Inc. CDZ Class I 1997-06-16
K964368 ELECSYS CEA ASSAY Boehringer Mannheim Corp. JIT Class II 1997-06-16
K971162 LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR Genzyme Corp. LBS Class I 1997-06-16
K971779 TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA Monobind CDP Class II 1997-06-16
K971709 TOTAL THROXINE MICROPLATE EIA(225-300) Monobind KLI Class II 1997-06-16
K971111 TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER Tri-Tech, Inc. JKA Class II 1997-06-16
K972004 ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS Alko Diagnostic Corp. CGZ Class II 1997-06-16
K971276 GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER Bayer Corp. CFR Class II 1997-06-16
K971902 ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT Roche Diagnostic Systems, Inc. LBS Class I 1997-06-16
K971952 LYPHOCHEK HYPERTENSION MARKERS CONTROL (CAT. NO. 600) Bio-Rad JJY Class I 1997-06-16
K971190 N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR Genzyme Corp. LBS Class I 1997-06-16
K971954 LIQUICHEK URINE CHEMISTRY CONTROL (CAT.NO. 397,398) Bio-Rad JJY Class I 1997-06-11
K971886 ACCUTEST HCG-URINE Unotech Diagnostics, Inc. JHI Class II 1997-06-11
K971505 SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT Beckman Instruments, Inc. CHH Class I 1997-06-11
K971817 OLYMPUS CK-MB REAGENT Olympus America, Inc. JLB Class I 1997-06-11
K970735 BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL Randox Laboratories, Ltd. LBS Class I 1997-06-06
K970386 ACS ESTADIOL-6 II Chiron Diagnostics Corp. CHP Class I 1997-06-04
K963018 BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS Bio-Rad CEF Class I 1997-06-04
K971220 GREINER VACUETTE BLOOD COLLECTION TUBE Greiner America, Inc. JKA Class II 1997-06-04
K970905 SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT Beckman Instruments, Inc. CHI Class I 1997-06-04
K964660 PARAMAX CHOLESTEROL REAGENT Dade Intl., Inc. CHH Class I 1997-06-04
K971283 SYNCHRON SYSTEMS CAL 5 PLUS Beckman Instruments, Inc. JIX Class II 1997-06-03
K971396 CK REAGENT Carolina Liquid Chemistries Corp. CGS Class II 1997-05-29
K971345 CHOL OR CHOLESTEROL Carolina Liquid Chemistries Corp. CHH Class I 1997-05-29
K971113 DMA TRIGLYCERIDES PROCEDURES Data Medical Associates, Inc. CDT Class I 1997-05-29
K971477 UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) Trace America, Inc. CDQ Class II 1997-05-27
K971777 QUANTEX ASO-CRP-RF CONTROL Instrumentation Laboratory CO JJT Class I 1997-05-27
K971485 URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) Trace America, Inc. CDO Class I 1997-05-27
K971312 IMMULITE PYRILINKS-D Diagnostic Products Corp. JMM Class I 1997-05-27
K970933 AUTO HDL CHOLESTEROL CALIBRATOR Pointe Scientific, Inc., JIS Class II 1997-05-23
K971333 SYNCHRON SYSTEMS ALKALINE PHOSPHATASE REAGENT, CHOLINESTERASE REAGENT, GAMMA-GLUTAMYL TRANSFERASE REAGENT, LACTATE DEHYD Beckman Instruments, Inc. JIX Class II 1997-05-23
K971269 DSL ACTIVE T4 EIA Diagnostic Systems Laboratories, Inc. KLI Class II 1997-05-22
K971270 DSL ACTIVE T3 EIA Diagnostic Systems Laboratories, Inc. CDP Class II 1997-05-22
K964635 NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT Nichols Institute Diagnostics JKR Class II 1997-05-21
K970919 SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT Beckman Instruments, Inc. KNK Class I 1997-05-21
K964506 ROCHE COBAS AMPLICOR ANALYZER Roche Molecular Systems, Inc. JJF Class I 1997-05-21
K971526 ACE HDL-C REAGENT Schiapparelli Biosystems, Inc. LBS Class I 1997-05-21
K971177 IMMULITE VITAMIN B12 (LKVB1,LKVB5) Diagnostic Products Corp. CDD Class II 1997-05-16
K971463 ALP REAGENT SET Carolina Liquid Chemistries Corp. CJE Class II 1997-05-16
K971524 TOTAL PROTEIN OR TP Carolina Liquid Chemistries Corp. CEK Class II 1997-05-16
K971203 SYNCHRON SYSTEMS THYROXINE REAGENT Beckman Instruments, Inc. KLI Class II 1997-05-16
K970915 DSL ESTRONE-SULFATE RIA Diagnostic Systems Laboratories, Inc. CGF Class I 1997-05-16
K971239 GREINER VACUETTE BLOOD COLLECTION TUBE Greiner America, Inc. JKA Class II 1997-05-12
K971236 GREINER VACUETTE BLOOD COLLECTION TUBE Greiner America, Inc. JKA Class II 1997-05-12
K971353 DSL ACTIVE NON-EXTRACTION IGF-I ELISA Diagnostic Systems Laboratories, Inc. CFL Class I 1997-05-12
K970556 SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc. CGA Class II 1997-05-12
K965103 WINMAX SOFTWARE SYSTEMS Diagnostic Products Corp. JJF Class I 1997-05-09
K970710 STAT PROFILE ULTRA M ANALYZER Nova Biomedical Corp. CHL Class II 1997-05-09
K971286 EZ SURE (EXCEL) URINE MIDSTREAM PREGNANCY HOME TEST Excel Scientific, Inc. LCX Class II 1997-05-08
K970684 LACTATE DEHYDROGENASE (LD) Randox Laboratories, Ltd. CFJ Class II 1997-05-07
K970986 WAKO DIRECT BILIRUBIN V Wako Chemicals USA, Inc. CIG Class II 1997-05-07
K971466 SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT) Carolina Liquid Chemistries Corp. JQB Class I 1997-05-06
K971221 GREINER VACUETTE BLOOD COLLECTION TUBE Greiner America, Inc. GIM Class II 1997-05-02
K971445 ALB OR ALBUMIN Carolina Liquid Chemistries Corp. CIX Class II 1997-05-02
K971398 LD-L REAGENT Carolina Liquid Chemistries Corp. CFJ Class II 1997-05-02
K971141 FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM Dade Chemistry Systems, Inc. CEC Class II 1997-04-28
K971122 ACCULINE PREGNANCY TEST Genix Biotek, Inc. JHI Class II 1997-04-25
K971014 LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS Lifescan, Inc. JJX Class I 1997-04-23
K964756 PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT Wano-Tech Corp. JFH Class II 1997-04-23

13,065 clearances in the Clinical Chemistry panel. Data: openFDA.