meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
45
Latest Decision
2002-06-03

Clearances · page 31 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K021448 MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM Roche Diagnostics Corp. NBW Class II 2002-06-03
K020945 AXSYM INTACT PTH, MODEL 2G06 Diagnostic Systems Laboratories, Inc. CEW Class II 2002-05-31
K020950 SPECTRAL'S 2 IN 1 (TNI-MYO) Spectral Diagnostics, Inc. MMI Class II 2002-05-24
K021409 AT HOME OVULATION TEST, MODEL 9032 Phamatech, Inc. CEP Class I 2002-05-24
K021498 LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL Bio-Rad JJT Class I 2002-05-24
K020439 STATUS HCG SERUM/URINE Princeton BioMeditech Corp. JHI Class II 2002-05-23
K020801 QUICKVUE ONE-STEP HCG-COMBO Quidel Corp. JHI Class II 2002-05-17
K020799 QUICKVUE ONE-STEP HCG-URINE Quidel Corp. JHI Class II 2002-05-17
K020816 IRON-PC-SL ASSAY MODEL # 151-10, 151-26 Diagnostic Chemicals , Ltd. JIY Class I 2002-05-14
K021163 OCTEIA 25-HYDROXY VITAMIN D Immunodiagnostic Systems , Ltd. MRG Class II 2002-05-10
K020724 DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131 Dade Behring, Inc. MRR Class I 2002-05-09
K020723 DIMENSION ALDL CALIBRATOR, MODEL DC131 Dade Behring, Inc. JIT Class II 2002-05-08
K020625 SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346 Helena Laboratories CIN Class II 2002-05-06
K020210 GLUCOMETER DEX BLOOD GLUCOSE SYSTEM (MODIFIED) Bayer Group Diagnostics NBW Class II 2002-04-30
K020208 GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED) Bayer Group Diagnostics NBW Class II 2002-04-29
K020894 CALIBRATING MATERIAL, CAL-PAK, BUFFERS Mission Diagnostics JIT Class II 2002-04-29
K021155 MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL Medical Analysis Systems, Inc. JJW Class I 2002-04-29
K020488 CARESIDE TRGLYCERIDE Careside, Inc. CDT Class I 2002-04-15
K020817 LIQUICHEK URINE CHEMISTRY CONTROL Bio-Rad Laboratories, Inc. JJY Class I 2002-04-12
K020575 ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS Elan Diagnostics MRR Class I 2002-04-12
K020662 MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/ CALIBRATORS Ortho-Clinical Diagnostics MMI Class II 2002-04-12
K020454 CHEMISTRY CALIBRATOR Jas Diagnostics, Inc. JIT Class II 2002-04-08
K020548 FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300 Monobind CEC Class II 2002-04-05
K012221 SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM Biosafe Laboratories, Inc. JKA Class II 2002-04-03
K020935 HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706 Hemocue, Inc. CGA Class II 2002-04-03
K020467 SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452 Helena Laboratories CFE Class II 2002-03-29
K014030 1,25-DIHYDROXYVITAMIN D125I RIA DiaSorin, Inc. MRG Class II 2002-03-26
K020596 CALIBRATING MATERIAL,CAL-PAK, CAL & SLOPE STANDARDS Diamond Diagnostics, Inc. JIT Class II 2002-03-23
K020450 VALIDATE CHEM 8 CALIBRATION VERIFICATION TEST SET; MODEL 108 Maine Standards Co. JJY Class I 2002-03-21
K014139 DIABETES ASSISTANT SOFTWARE Roche Diagnostics Corp. CGA Class II 2002-03-21
K020175 URS-IG (GLUCOSE TEST) Teco Diagnostics JIL Class II 2002-03-21
K020237 IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3 Consolidated Technology JJY Class I 2002-03-19
K020217 ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY Bayer Diagnostics Corp. JJX Class I 2002-03-15
K020438 SAS VALUE HCG Sa Scientific, Inc. JHI Class II 2002-03-08
K013662 MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS Quantimetrix Corp. JHO Class I 2002-03-08
K020369 ELECSYS ANTI-TG CALCHECK Roche Diagnostics Corp. JJX Class I 2002-03-06
K020128 ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500 Diagnostic Systems Laboratories, Inc. JHI Class II 2002-03-01
K020521 MODIFICATION TO VIGIL LIPID CONTROL Beckman Coulter, Inc. JJY Class I 2002-03-01
K020282 JAS AMYLASE LIQUID REAGENT Jas Diagnostics, Inc. JFJ Class II 2002-02-28
K012975 SOF-TACT DIABETES MANAGEMENT SYSYEM; SOF-TACT BLOOD GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS Abbott Laboratories NBW Class II 2002-02-28
K014295 STAT PROFILE PHOX ANALYZER Nova Biomedical Corp. CHL Class II 2002-02-28
K013874 CLEARPLANE EASY OVULATION TEST Unipath , Ltd. CEP Class I 2002-02-19
K014167 LIBERTY BLOOD GLUCOSE MONITORING SYSTEM Polymedica Pharmaceuticals, U.S.A., Inc.] NBW Class II 2002-02-19
K013397 PACIFIC HEMOSTASIS REFERENCE EMULSION Fisher Diagnostics JIX Class II 2002-02-15
K013342 EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. Chay Medical, LLC CGA Class II 2002-02-15
K020232 HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM Hypoguard USA, Inc. CGA Class II 2002-02-12
K014032 OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA Olympus America, Inc. LBS Class I 2002-02-08
K014120 TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA) Diagnostics Biochem Canada, Inc. CDZ Class I 2002-02-08
K014015 OLYMPUS HDL CHOLESTEROL REAGENT; OLYMPUS HDL CHOLESTEROL CALIBRATOR; OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA Olympus America, Inc. LBS Class I 2002-02-08
K020148 pHoenix ISE Reagents FOR Olympus AU Chemistry Systems Phoenix Diagnostics, Inc. CGZ Class II 2002-02-04
K013971 BD VACUTAINER SAFETY COAGULATION TUBE Becton, Dickinson & CO JKA Class II 2002-02-01
K012966 ROCHE COBAS TAQMAN ANALYZER Roche Molecular Systems, Inc. JJF Class I 2002-02-01
K014104 VACUETTE EDTA K2 TUBES Greiner Vacuette North America, Inc. PJE Class II 2002-02-01
K020129 PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE Phoenix Diagnostics, Inc. JIX Class II 2002-02-01
K014105 SPECTRAL'S TROPONIN I Spectral Diagnostics, Inc. MMI Class II 2002-02-01
K010790 CORTISOL LIA Kmi Diagnostics, Inc. CGR Class II 2002-01-29
K013983 WIENER LAB. ALP 405 Wiener Laboratories Saic CJE Class II 2002-01-28
K013938 IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE Diametrics Medical, Inc. KHP Class I 2002-01-28
K014103 SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR Beckman Coulter, Inc. MRR Class I 2002-01-28
K013899 VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS Ortho-Clinical Diagnostics CDD Class II 2002-01-24
K013857 AIMSTEP PREGNANCY Germaine Laboratories, Inc. DHA Class II 2002-01-22
K013783 AUTION MAX AX-4280 URINALYSIS SYSTEM International Remote Imaging Systems KQO Class I 2002-01-18
K012943 THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE Quantech , Ltd. NAL Class II 2002-01-18
K013912 CREATINE KINASE (CK-NAC) Jas Diagnostics, Inc. CGS Class II 2002-01-18
K012789 MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123 Morax JHO Class I 2002-01-17
K013729 STAT PROFILE PHOX BASIC ANALYZER Nova Biomedical Corp. CHL Class II 2002-01-15
K013978 SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT Beckman Coulter, Inc. JFJ Class II 2002-01-15
K013062 BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT Biocheck, Inc. MMI Class II 2002-01-08
K013702 VICTORCH HCG TEST STRIP Victorch Meditek, Inc. JHI Class II 2001-12-27
K013678 VICTORCH MEDITEK'S HCG TEST CARD Victorch Meditek, Inc. DHA Class II 2001-12-27
K013698 AST (SGOT) Jas Diagnostics, Inc. CIT Class II 2001-12-21
K013900 VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS Ortho-Clinical Diagnostics JJX Class I 2001-12-21
K011953 WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA Wiener Laboratories Saic CGA Class II 2001-12-21
K013371 UBIT-IR300 INFRARED SPECTROMETRY SYSTEM Otsuka Pharmaceutical Co., Ltd. JJQ Class I 2001-12-21
K013606 ACS 180 HOMOCYSTEINE ASSAY Bayer Diagnostics Corp. LPS Class II 2001-12-21
K013995 MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL Medical Analysis Systems, Inc. JJY Class I 2001-12-21
K013466 SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343 Helena Laboratories JHO Class I 2001-12-21
K013850 STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE Diamond Diagnostics, Inc. JIT Class II 2001-12-21
K013652 WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002 Wiener Laboratories Saic CIC Class II 2001-12-21
K014099 BIOSCANNER PLUS Polymer Technology Systems, Inc. NBW Class II 2001-12-21
K013406 ADVIA CENTAUR HOMOCYSTEINE ASSAY Bayer Diagnostics Corp. LPS Class II 2001-12-18
K014034 MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO) Beckman Coulter, Inc. JFL Class II 2001-12-18
K013451 PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES Phoenix Diagnostics, Inc. CGZ Class II 2001-12-18
K014024 MODIFICATION TO ALPHA DX SYSTEM First Medical, Inc. MMI Class II 2001-12-18
K013178 DC-UIBC-CO2-CAL, MODEL SE-153 Diagnostic Chemicals , Ltd. JIX Class II 2001-12-18
K013907 INVERNESS MEDICAL EARLY PREGNANCY TEST Cambridge Diagnostics Ireland, Ltd. LCX Class II 2001-12-18
K011323 HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102 Salimetrics, LLC NHG Class II 2001-12-17
K012820 AIA-PACK CTNI 2ND-GEN ASSAY Tosoh Medics, Inc. MMI Class II 2001-12-14
K013992 NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY Nichols Institute Diagnostics CEW Class II 2001-12-13
K013734 MAS LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL 1 AND 2, DADE LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL Medical Analysis Systems, Inc. JJY Class I 2001-12-07
K012324 ACCU-CHEK ACTIVE TEST SYSTEM Roche Diagnostics Corp. NBW Class II 2001-12-05
K013323 TCI-31 LIFELONG OVULATION TESTER Tci New York CEP Class I 2001-12-05
K012014 MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM Abbott Diabetes Care, Inc. NBW Class II 2001-12-05
K011479 ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM Inverness Medical Innovations, Inc. CGA Class II 2001-11-30
K013145 WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML CAT. NR. 1751302 AND 20 * 2 ML CAT NR. Wiener Laboratories Saic CIT Class II 2001-11-27
K011963 ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY Bayer Corp. CFR Class II 2001-11-20
K013265 VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007 Maine Standards Co. JJY Class I 2001-11-20
K013332 LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A=E FOR BECKMAN COULTER IMMAGE Cliniqa Corporation JJY Class I 2001-11-20
K013068 BIOSCANNER 2000 Polymer Technology Systems, Inc. CGA Class II 2001-11-20
K013566 IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6 Diagnostic Products Corp. CEW Class II 2001-11-20

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