meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
49
Latest Decision
2003-03-26

Clearances · page 29 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K030705 CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3, AND TRI LEVEL Cliniqa Corporation JJY Class I 2003-03-26
K030768 CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL Cliniqa Corporation JJT Class I 2003-03-21
K030057 SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST Spectral Diagnostics, Inc. MMI Class II 2003-03-19
K030482 WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553 Wiener Laboratories JJY Class I 2003-03-19
K030621 ATAC CALIBRATOR Elan Diagnostics JIX Class II 2003-03-19
K024305 WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006 Wiener Laboratories Saic JIX Class II 2003-03-18
K022096 URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM Bayer Diagnostics Corp. KNK Class I 2003-03-18
K030628 SAS RSV CONTROL KIT Sa Scientific, Inc. JJX Class I 2003-03-17
K030679 MAS LIPID LEVEL 1 AND 2 Medical Analysis Systems, Inc. JJY Class I 2003-03-14
K023105 ATAC CALCIUM REAGENT AND ATAC CALIBRATOR Elan Diagnostics CIC Class II 2003-03-13
K030566 LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A-E FOR THE OLYMPUS AU SERIES CHEMISTRY IMMUNO ANALYZERS Cliniqa Corporation JJY Class I 2003-03-13
K030010 ATAC PAK MAGNESIUM REAGENT Elan Diagnostics JGJ Class I 2003-03-10
K030015 ATAC PAK PHOSPHORUS REAGENT Elan Diagnostics CEO Class I 2003-03-07
K030006 ATAC PAK ALBUMIN REAGENT Elan Diagnostics CIX Class II 2003-03-07
K030452 BAYER LIGAND PLUS 1, 2, 3 CONTROLS Bayer Diagnostics Corp. JJY Class I 2003-03-03
K024062 ASCENSIA BREEZE BLOOD GLUCOSE METER Bayer Corp. CGA Class II 2003-03-03
K024182 PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS Precision Systems, Inc. CDQ Class II 2003-03-03
K030258 FIRST RESPONSE PREGNANCY TEST Armkel, LLC LCX Class II 2003-02-25
K024281 WAKO L-TYPE GLUCOSE 2 Wako Chemicals USA, Inc. CFR Class II 2003-02-24
K024193 MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/CALIBRATORS Ortho-Clinical Diagnostics MMI Class II 2003-02-21
K030286 TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL Biosite Incorporated NBC Class II 2003-02-21
K023824 ALBUMIN COBALT BINDING TEST (ACB TEST) Ischemia Technologies, Inc. NJV Class II 2003-02-14
K023407 ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR Elan Diagnostics CGX Class II 2003-02-14
K024116 WIENER LAB. BILIRUBINA DIRECT AA Wiener Laboratories Saic CIG Class II 2003-02-12
K023944 BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST Bayer Corp. JHI Class II 2003-02-11
K030065 WAKO NEFA LINEARITY SET Wako Chemicals USA, Inc. JJX Class I 2003-02-11
K024194 ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS Lifescan, Inc. NBW Class II 2003-02-07
K023792 CALIBRATION PACK, MODELS A9100-101S AND A9100-103S Thermo Orion JIX Class II 2003-01-31
K030169 SETPOINT CHEMISTRY CALIBRATOR Bayer Healthcare, LLC JIX Class II 2003-01-31
K023764 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 Beckman Coulter, Inc. JJE Class I 2003-01-28
K030150 LINICAL PROTEIN 5 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY AND IMMAGE PROTEIN SYSTEMS Cliniqa Corporation JJY Class I 2003-01-28
K023971 VACUETTE TRACE ELEMENTS TUBES Greiner Bio-One Vacuette North America JKA Class II 2003-01-27
K023640 PICCOLO HDL TEST SYSTEM Abaxis, Inc. LBS Class I 2003-01-24
K023642 PICCOLO TOTAL CHOLESTEROL TEST SYSTEM Abaxis, Inc. CHH Class I 2003-01-24
K030102 ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3 Bayer Healthcare, LLC JJT Class I 2003-01-24
K023639 PICCOLO TRIGLYCERIDES TEST SYSTEM Abaxis, Inc. JGY Class I 2003-01-24
K024234 ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL Bayer Corp. NBW Class II 2003-01-23
K030089 TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS Biosite Incorporated JJY Class I 2003-01-23
K030074 LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS Cliniqa Corporation JIX Class II 2003-01-21
K030088 TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER CALIBRATION VERFICICATION CONTROLS Biosite Incorporated JJY Class I 2003-01-17
K023739 GLUCOSE-SL-C ASSAY, MODEL 257-30 Diagnostic Chemicals , Ltd. CFR Class II 2003-01-17
K030012 CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372 Beckman Coulter, Inc. JHX Class II 2003-01-17
K030067 VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS Ortho-Clinical Diagnostics MJX Class I 2003-01-17
K023544 GENZYME CONTRAST II HCG URINE/SERUM TEST Genzyme Corp. JHI Class II 2003-01-16
K013582 MAYBE?MOM MINI OVULATION MICROSCOPE Maybe?Mom CEP Class I 2003-01-16
K023840 ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 Bayer Diagnostics Corp. CKB Class II 2003-01-07
K023410 VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110 Maine Standards Co. JJY Class I 2003-01-06
K023638 CASSETTE/URINE HCG Ind Diagnostic, Inc. LCX Class II 2003-01-03
K023744 WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354 Wiener Laboratories Saic JHW Class II 2003-01-03
K023807 MODIFICATION TO ALKP Abbott Laboratories CJE Class II 2002-12-26
K023784 RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER Hemagen Diagnostics, Inc. LBR Class I 2002-12-24
K023841 AMMONIA ASSAY FOR THE ADVIA 1650 Bayer Diagnostics Corp. JIF Class I 2002-12-24
K023731 QUICKCHECK LIQUID CHEMISTRY CONTROL (ASSAYED AND UNASSAYED), LEVELS 1, 2, AND 3 Consolidated Technology JJY Class I 2002-12-24
K023396 AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) Pointe Scientific, Inc., CIJ Class II 2002-12-23
K023567 STAT PROFILE PHOX PLUS L ANALYZER Nova Biomedical Corp. CHL Class II 2002-12-20
K023480 ACCESS TOTAL BHCG Beckman Coulter, Inc. JHI Class II 2002-12-20
K023669 MAS CARDIOIMMUNE TL LOW LEVEL LIQUID ASSAYED CARDIAC MARKER CONTROL, DADE CARDIAC TL LOW LEVEL LIQUID ASSAYED CARDIAC MA Medical Analysis Systems, Inc. JJY Class I 2002-12-19
K024098 COBAS INTEGRA CREATININE PLUS VER.2 ASSAY Roche Diagnostics Corp. JFY Class II 2002-12-19
K023867 MAS T-MARKER, LEVEL 1,2 AND 3, DADE SPECIAL-T MARKER, LEVEL 1,2 AND 3 Medical Analysis Systems, Inc. JJY Class I 2002-12-17
K023091 ST AIA-PACK TESTOSTERONE ASSAY Tosoh Medics, Inc. CDZ Class I 2002-12-17
K023027 PREG-Q EARLY PREGNANCY TEST Yd Diagnostics LCX Class II 2002-12-16
K022683 SAS BLOOD/SERUM/URINE/URINE HCG Sa Scientific, Inc. JHI Class II 2002-12-16
K023397 ABBOTT ARCHITECT FOLATE Abbott Laboratories CGN Class II 2002-12-16
K023832 SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc. NBW Class II 2002-12-13
K023330 BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30 Diagnostic Chemicals , Ltd. CIG Class II 2002-12-11
K023928 MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL Medical Analysis Systems, Inc. JJW Class I 2002-12-11
K023876 VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 Ortho-Clinical Diagnostics, Inc. JIX Class II 2002-12-10
K023875 VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4 Ortho-Clinical Diagnostics, Inc. CIX Class II 2002-12-10
K023551 WIENER LAB GOT (AST) UV AA LIQUIDA Wiener Laboratories Saic CIT Class II 2002-12-09
K023549 WIENER LAB AMILASA 405 AA LIQUIDA Wiener Laboratories Saic JFJ Class II 2002-12-09
K023304 IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL Diagnostic Products Corp. JKR Class II 2002-12-09
K023550 WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA Wiener Laboratories Saic KNK Class I 2002-12-09
K023369 ACCESS TOTAL T4 ASSAY Beckman Coulter, Inc. KLI Class II 2002-12-09
K023219 BECTON DICKINSON DIABETES SOFTWARE Becton, Dickinson & CO NBW Class II 2002-12-06
K023661 LINICAL RF-CRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS Cliniqa Corporation JJY Class I 2002-12-06
K020883 ELECSYS PROBNP CALCHECK Roche Diagnostics Corp. JJX Class I 2002-11-29
K023699 CLEARBLUE EASY EARLY RESULT PREGNANCY TEST Unipath , Ltd. LCX Class II 2002-11-27
K023075 BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE Bd Vacutainer Systems Preanalyical Solutions JKA Class II 2002-11-25
K023331 BD VACUTAINER SST II PLUS TUBES Becton, Dickinson & CO JKA Class II 2002-11-25
K023093 ACCESS HYPERSENSITIVE HTSH ASSAY Beckman Coulter, Inc. JLW Class II 2002-11-25
K023352 VALIDATE CHEM 9 CALIBRATION VERIFICATION TEST SET, MODEL 109 Maine Standards Co. JJY Class I 2002-11-22
K022746 STAT PROFILE CRITICAL CARE XPRESS ANALYZER Nova Biomedical Corp. CHL Class II 2002-11-22
K023584 ASCENSIA DEX 2 DIABETES CARE SYSTEM Bayer Corp. NBW Class II 2002-11-20
K022516 ELECSYS PROBNP IMMUNOASSAY Roche Diagnostics Corp. NBC Class II 2002-11-19
K023126 AMEDITECH IMMUTEST HCG PREGANCY TEST Ameditech, Inc. LCX Class II 2002-11-18
K023268 PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS Phoenix Diagnostics, Inc. JIX Class II 2002-11-15
K023558 PTS PANELS LIPID PANEL TEST STRIPS Polymer Technology Systems, Inc. CHH Class I 2002-11-15
K022769 LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION Bionostics, Inc. JJX Class I 2002-11-13
K022829 INSTANT-VIEW LH OVULATION PREDICTING TEST Alfa Scientific Designs, Inc. CEP Class I 2002-11-05
K022682 RANDOX C-REACTIVE PROTEIN CALIBRATOR Randox Laboratories, Ltd. JIS Class II 2002-11-05
K022962 WIENER LAB. BILIRRUBINA TOTAL AA Wiener Laboratories Saic CIG Class II 2002-11-01
K022681 AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST (DEVICE OR CASSETTE) Azog, Inc. DHA Class II 2002-11-01
K022680 AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK) Azog, Inc. DHA Class II 2002-11-01
K023307 MAS DIABETES CONTROL - LYOPHILIZED ASSAYED DIABETES CONTROL Medical Analysis Systems, Inc. JJX Class I 2002-10-31
K022941 MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE TESTING Abbott Laboratories LFR Class II 2002-10-28
K021541 NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT Perkinelmer Life Sciences JNB Class II 2002-10-28
K023208 CEDIA CYCLOSPORINE PLUS ASSAY Microgenics Corp. MKW Class II 2002-10-24
K023194 SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM Lifescan, Inc. CGA Class II 2002-10-24
K023158 RANDOX APOLIPOPROTEIN CALIBRATOR Randox Laboratories, Ltd. JIX Class II 2002-10-24
K023250 LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR THE BECKMAN-COULTER IMMAGE Cliniqa Corporation JJY Class I 2002-10-17

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