meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
56
Latest Decision
1998-02-25

Clearances · page 41 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K980556 LIQUICHEK CARDIAC MARKERS CONTROL LT Bio-Rad JJT Class I 1998-02-25
K980012 CREATINE KINASE REAGENT Ac Biochemicals, Inc. JHX Class II 1998-02-25
K974784 AVL OPTI CRITICAL CARE ANALYZER Avl Scientific Corp. CEM Class II 1998-02-24
K974909 SYNERMED CREATININE REAGENT KIT Synermed Intl., Inc. CGX Class II 1998-02-24
K973900 TESTOTERONE ELISA Kmi Diagnostics, Inc. CDZ Class I 1998-02-24
K972075 VACUTAINER BRAND PPT PLASMA PREPARATION TUBE Becton Dickinson Vacutainer Systems PJE Class II 1998-02-24
K972904 DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL Casco Standards JJY Class I 1998-02-20
K973395 EPISCREEN ORAL SPECIMEN COLLECTION DEVICE Epitope, Inc. PJD Class II 1998-02-13
K974779 ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER Abbott Laboratories JJE Class I 1998-02-13
K974833 CK-NAC REAGENT Intersect Systems, Inc. CGS Class II 1998-02-13
K974874 BILIRUBIN-SL (TOTAL) ASSAY Diagnostic Chemicals, Ltd. (Usa) CIG Class II 1998-02-12
K974606 RANDOX MAGNESIUM Randox Laboratories, Ltd. JGJ Class I 1998-02-12
K980178 OXYHEMOGLOBIN CONTROL FOR CO-OXIMETRY Bionostics, Inc. JJY Class I 1998-02-12
K980316 ALKALINE PHOSPHATASE-SL ASSAY CATALOGUE NUMBER 309-10, 309-30 Diagnostic Chemicals , Ltd. CJE Class II 1998-02-12
K974651 ABBOTT AXSYM SYSTEM Abbott Laboratories JJE Class I 1998-02-12
K980205 SAN DIEGO BIOTECH HCG PREGNANCY DIPSTICK TEST San Diego Biotech JHI Class II 1998-02-12
K980180 2700 SAMPLE MANAGER Waters Corporation JQW Class I 1998-02-12
K974811 ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL Boston Biomedica, Inc. JJX Class I 1998-02-10
K973350 BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST Bio-Rad JLX Class I 1998-02-09
K980130 ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM Radiometer America, Inc. CHL Class II 1998-02-09
K980120 DIGENE DML 2000 MICROPLATE LUMINOMETER Digene Corp. JJQ Class I 1998-02-06
K974873 VACUETTE (MULTI-USE HOLDER) Greiner Meditech, Inc. JKA Class II 1998-02-05
K980098 VACUTAINER BRAND PRONTO NEEDLES HOLDER Becton Dickinson Vacutainer Systems JKA Class II 1998-02-05
K974526 EASYBLOOD GAS ANALYZER Medica Corp. CHL Class II 1998-02-05
K980057 CARESIDE BUN Exigent Diagnostics, Inc. CDQ Class II 1998-02-05
K980013 AMYLASE Ac Biochemicals, Inc. CIJ Class II 1998-02-04
K980042 CARESIDE TOTAL PROTEIN Exigent Diagnostics, Inc. CEK Class II 1998-02-04
K980041 CARESIDE ALBUMIN Exigent Diagnostics, Inc. CIX Class II 1998-02-04
K973938 ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER Sfri, Inc. JJQ Class I 1998-02-04
K974839 ALPHA DX ANALYZER 01-0100, ALPHA DX MYO/CK/CK-MB/TNI CARDIAC PANEL TEST KIT 03-0001, ALPHA DX CK/CK-MB PANEL TEST KIT First Medical, Inc. MMI Class II 1998-02-04
K980088 T-UPTAKE MICROPLATE EIA Monobind KHQ Class II 1998-02-04
K980028 ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) Trace America, Inc. CKA Class I 1998-02-02
K974607 RANDOX CALCIUM Randox Laboratories, Ltd. CJY Class II 1998-02-02
K974027 AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK Alfa Biotech (Uk) , Ltd. CDP Class II 1998-02-02
K974508 DBEST ONE-STEP OVULATION TEST Ameritek, Inc. CEP Class I 1998-02-02
K980030 AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) Trace America, Inc. CIT Class II 1998-01-30
K974858 PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30 Diagnostic Chemicals , Ltd. CEO Class I 1998-01-30
K974825 BOEHRINGER MANNHEIM C.F.A.S. - HDL/LDL-C-PLUS Boehringer Mannheim Corp. JIX Class II 1998-01-30
K974762 STAT TRACKS Awareness Technology, Inc. JJQ Class I 1998-01-28
K980055 CARESIDE GLOBULIN Exigent Diagnostics, Inc. JGE Class I 1998-01-28
K980135 QUALICHECK5+ MODELS S7730, S7740, S7750, S7760 Radiometer America, Inc. JJS Class I 1998-01-28
K974613 VIROTROL III Blackhawk Biosystems, Inc. JJY Class I 1998-01-27
K974451 ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc. CGA Class II 1998-01-26
K974615 QUICKSTICK PRO HCG TEST Phamatech JHI Class II 1998-01-26
K974733 BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL Boehringer Mannheim Corp. LBR Class I 1998-01-26
K974260 PYRILINKS-D ASSAY KIT Metra Biosystems, Inc. JMM Class I 1998-01-26
K974821 BLUETEST(R) PREGNANCY TEST, RAPIDVUE(R) PREGNANCY TEST Quidel Corp. LCX Class II 1998-01-26
K974851 SAN DIEGO BIOTECH HCG PREGNANCY URINE TEST San Diego Biotech JHI Class II 1998-01-22
K974826 BM PRECIPATH(R) HDL/LDL-C CONTROL Boehringer Mannheim Corp. JJY Class I 1998-01-22
K972669 MTM BIOSCANNER 1000 TEST SYSTEM CONSISTING OF MTM BIOSCANNER 1000 METER, MTM BIOSCANNER G TEST STRIP, NORMAN GLUCOSE CON Polymer Technology Systems, Inc. CGA Class II 1998-01-22
K974859 LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30 Diagnostic Chemicals , Ltd. CFJ Class II 1998-01-22
K974822 AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROL Avl Scientific Corp. JJY Class I 1998-01-22
K974818 ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM Radiometer America, Inc. MMI Class II 1998-01-16
K974644 VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS Johnson & Johnson Clinical Diagnostics, Inc. JJX Class I 1998-01-13
K973547 TRIAGE STATMETER Biosite Incorporated KHO Class I 1998-01-13
K974605 RANDOX INORGANIC PHOSPHOROUS Randox Laboratories, Ltd. CEO Class I 1998-01-09
K974827 TRIAGE(R) CARDIAC PANEL CALIBRATION VERIFICATION CONTROLS, TRIAG (R) MYOGLOBIN CALIBRATION VERIFICATION CONTROLS, TRIAGE Biosite Incorporated JJY Class I 1998-01-08
K973860 OVULON MONITOR Conception Technology, Inc. NGE Class I 1998-01-07
K973869 TRACE REAGENT LINE FOR THE COBAS MIRA Trace America, Inc. CKA Class I 1998-01-07
K974609 REP CHOLESTEROL PROFILE CONTROL-II Helena Laboratories JJX Class I 1998-01-06
K974604 RANDOX IRON Randox Laboratories, Ltd. JMO Class I 1998-01-06
K974634 IMMULITE FREE T3 Diagnostic Products Corp. CDP Class II 1998-01-02
K974368 AIMSTICK PBD PREGNANCY Germaine Laboratories, Inc. DHA Class II 1998-01-02
K971653 GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM Clinical Diagnostics, Inc. CGA Class II 1998-01-02
K974620 AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) Trace America, Inc. JIF Class I 1998-01-02
K974512 AIMSTICK PBD COMBO PREGNANCY Germaine Laboratories, Inc. DHA Class II 1998-01-02
K974374 SAFE NEEDLE DIRECT BLOOD TRANSFER DEVICE, MODEL TA-STV Ohmeda Medical JKA Class II 1998-01-02
K974425 BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST, LIFESIGN HCG-ONE STEP PREGNANCY TEST Princeton BioMeditech Corp. DHA Class II 1997-12-24
K974159 OSOM HCG-URINE TEST MODEL 101 Wyntek Diagnostics, Inc. JHI Class II 1997-12-24
K974262 SYSCOS IDC - G, IDC, BSC, IDC - G Scantibodies Laboratory, Inc. MJX Class I 1997-12-24
K974306 SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA Sangui Biotech, Inc. CEW Class II 1997-12-23
K973988 RDI HOMOGENEOUS HDL CHOLESTEROL TEST Reference Diagnostics, Inc. LBS Class I 1997-12-22
K974551 SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY Sealite Sciences, Inc. CEC Class II 1997-12-22
K973825 MIDSTREAM HOME REGNANCY TEST Germaine Laboratories, Inc. DHA Class II 1997-12-19
K974154 CHOICE ACCU-TEST PREGNANCY TEST KIT Sa Scientific, Inc. LCX Class II 1997-12-19
K974290 MICROPROTEIN STANDARD KIT Verichem Laboratories, Inc. JIX Class II 1997-12-19
K974052 QUICKVUE SEMI-Q HCG-COMBO Quidel Corp. JHI Class II 1997-12-19
K974021 SIGNAL PREGNANCY TEST KIT Sa Scientific, Inc. LCX Class II 1997-12-19
K973284 COBAS INTEGRA HDL-CHOLESTEROL DIRECT Roche Diagnostic Systems, Inc. CHH Class I 1997-12-18
K974396 IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE Diametrics Medical, Inc. CHL Class II 1997-12-18
K974452 VIGIL LIPID CONTROL Beckman Instruments, Inc. JJY Class I 1997-12-17
K971944 LACTEST I Jwt, Inc. KHP Class I 1997-12-17
K974421 ELECSYS CK-MB STAT Boehringer Mannheim Corp. JHY Class II 1997-12-17
K974125 IL TEST AMYLASE Instrumentation Laboratory CO JFJ Class II 1997-12-17
K974337 IL TEST UREA NITROGEN Instrumentation Laboratory CO CDQ Class II 1997-12-17
K973957 DBEST ONE-STEP HCG SERUM/URINE TEST Ameritek, Inc. JHI Class II 1997-12-17
K974322 ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM Europa Scientific, Ltd. DOP Class I 1997-12-16
K972473 ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM DATA DOCK Lifescan, Inc. CGA Class II 1997-12-16
K973676 PRESTIGE AQUEOUS GLUCOSE CONTROL LOW, PRESTIGE AQUEOUS GLUCOSE CONTROL HIGH Sorrento Biochemical, Inc. JJX Class I 1997-12-16
K973677 DIASCAN AQUEOUS GLUCOSE CONTROL LOW, DIASCAN AQUEOUS GLUCOSE CONTROL HIGH Sorrento Biochemical, Inc. JJX Class I 1997-12-15
K973678 ULTRA + AQUEOUS GLUCLOSE CONTROL LOW ULTRA + AQUEOUS GLUCOSE CONTROL HIGH Sorrento Biochemical, Inc. JJX Class I 1997-12-15
K973932 BECKMAN CALIBRATOR 2 (CAL2) Beckman Instruments, Inc. JIX Class II 1997-12-15
K973662 ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS Boehringer Mannheim Corp. LFR Class II 1997-12-15
K970277 URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) Astoria-Pacific, Inc. KQP Class II 1997-12-11
K974461 TRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE CK-MB CONTROL, TRIAGE MYOGLOBIN CONTROL Biosite Incorporated JJT Class I 1997-12-10
K974053 AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10 Diagnostic Chemicals , Ltd. JFJ Class II 1997-12-08
K974383 ELECSYS CALCHECK VITAMIN B12 Boehringer Mannheim Corp. JJX Class I 1997-12-08
K974384 ELECSYS CALCHECK FOLATE Boehringer Mannheim Corp. JJY Class I 1997-12-08
K973616 TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM Bayer Corp. MMI Class II 1997-12-05
K974003 ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30 Diagnostic Chemicals , Ltd. CKA Class I 1997-12-05

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