meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
47
Latest Decision
2000-04-13

Clearances · page 35 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K000810 QUALITROL LIPID CONTROL, LEVELS 1 AND 2 Consolidated Technologies of Wisconsin JJY Class I 2000-04-13
K000777 SAMPLOK Itl Corporation Pty, Ltd. JKA Class II 2000-04-11
K000471 FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT Future Diagnostics B.V. CEW Class II 2000-04-11
K993867 BAYER ADVIA IMS SYSTEM Bayer Corp. CIG Class II 2000-04-10
K992781 ARCHITECH AFP MASTERCHECK, MODEL 6C01-05 Bio-Rad JJX Class I 2000-04-05
K000375 RANDOX CALCIUM Randox Laboratories, Ltd. CIC Class II 2000-04-05
K993925 WAKO L-TYPE UN TEST Wako Chemicals USA, Inc. CDQ Class II 2000-04-03
K000483 RANDOX ALBUMIN Randox Laboratories, Ltd. CJW Class II 2000-03-31
K994278 ACCESS OSTASE IMMUNOENZYMETRIC ASSAY Beckman Coulter, Inc. CIN Class II 2000-03-28
K000600 SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS Syva Co., Dade Behring, Inc. KLI Class II 2000-03-27
K000576 ELECSYS CORTISOL CALCHECK Roche Diagnostics Corp. JIX Class II 2000-03-21
K000716 ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER Beckman Coulter, Inc. JHX Class II 2000-03-20
K000103 AVL OPTI R ANALYZER Avl Scientific Corp. CHL Class II 2000-03-20
K000583 FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM Selfcare, Inc. CGA Class II 2000-03-17
K000042 ELECSYS B-CROSSLAPS CALCHECK Roche Diagnostics Corp. JJX Class I 2000-03-17
K000270 ELECSYS CORTISOL TEST SYSTEM Roche Diagnostics Corp. JJY Class I 2000-03-07
K000231 TRIAGE BNP CALIBRATION VERIFICATION CONTROLS Biosite Incorporated JJX Class I 2000-03-02
K993941 UBAS Marukin Diagnostics KWX Class II 2000-03-02
K994291 DIMENSION SPECIAL PROTEIN CALIBRATOR Dade Behring, Inc. JIT Class II 2000-03-01
K000230 TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLS Biosite Incorporated JJX Class I 2000-02-29
K000318 BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM Bionostics, Inc. JJX Class I 2000-02-28
K000056 BIO-LIPID HUMAN SERUM HDL AND LDL CALIBRATORS Biocell Laboratories, Inc. JJX Class I 2000-02-24
K000364 ACCU-CHEK COMPLETE METER Roche Diagnostics Corp. LFR Class II 2000-02-23
K000257 IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6 Diagnostic Products Corp. JFH Class II 2000-02-23
K000365 ACCU-CHEK ADVANTAGE METER Roche Diagnostics Corp. CGA Class II 2000-02-23
K000055 CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17 Diagnostic Chemicals , Ltd. CGX Class II 2000-02-18
K992662 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM Bayer Corp. MSJ Class I 2000-02-15
K000116 QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3 Consolidated Technologies, Inc. JJY Class I 2000-02-15
DEN990008 WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000 Wallac, Inc. NAK Class II 2000-02-15
K000331 SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR Beckman Coulter, Inc. JIS Class II 2000-02-10
K000102 GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150 Teco Diagnostics CFR Class II 2000-02-08
K994438 BILICHEK NON-INVASIVE BILIRUBIN ANALYZER Spectrx, Inc. MQM Class I 2000-02-04
K994168 SYNCHRON LX SYSTEMS PREALBUMIN CALIBRATOR Beckman Coulter, Inc. JIS Class II 2000-02-03
K994227 ADVANTAGE HCG TEST (URINE/SERUM) Advantage Diagnostics Corp. JHI Class II 2000-02-03
K994169 SYNCHRON CX SYSTEMS PREALBUMIN CALIBRATOR Beckman Coulter, Inc. JIS Class II 2000-02-03
K994035 IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15 Diagnostic Chemicals , Ltd. JIR Class I 2000-02-01
K994148 3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM Implant Innovations, Inc. JQC Class I 2000-02-01
K994346 ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM Sendx Medical, Inc. CHL Class II 2000-02-01
K994085 IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5 Diagnostic Products Corp. DHA Class II 2000-01-28
K994115 TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE Dade Behring, Inc. JMO Class I 2000-01-28
K990039 GAMBRO DQM 200 Gambro Healthcare LFP Class II 2000-01-27
K994114 DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR Dade Behring, Inc. JIS Class II 2000-01-20
K994189 OLYMPUS CREATINE KINASE REAGENT OSR6179/6279 Olympus Diagnostica GmbH CGS Class II 2000-01-20
K993483 ACON ONE STEP HOME PREGNANCY TEST STRIP ACON Laboratories, Inc. LCX Class II 2000-01-20
K000067 ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H Teco Diagnostics CJE Class II 2000-01-20
K994200 ACCESS HYBRITECH PSA QC, MODEL 37209 Beckman Coulter, Inc. JJX Class I 2000-01-18
K994277 ACCESS OSTASE QC Beckman Coulter, Inc. JJX Class I 2000-01-14
K992684 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM Abbott Diabetes Care, Inc. LFR Class II 2000-01-14
K994439 ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306 Beckman Coulter, Inc. JHX Class II 2000-01-14
K993377 MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC) Polymer Technology Systems, Inc. NAQ Class I 2000-01-13
K994325 SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR Beckman Coulter, Inc. JIS Class II 2000-01-12
K992859 ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE Radiometer America, Inc. CHL Class II 2000-01-10
K993789 CLINICAL BLOOD GAS MIXTURE General Air Service and Supply CHL Class II 2000-01-10
K993210 ACCESS HYBRITECH FREE PSA QC, MODEL 37219 Beckman Coulter, Inc. JJX Class I 2000-01-05
K993850 URINALYSIS REAGENT STRIPS (10 PARAMETERS) International Newtech Development, Inc. JMT Class I 2000-01-03
K992148 HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT Morax CGS Class II 1999-12-29
K993853 K-ASSAY MULTI-ANALYTE CALIBRATOR Kamiya Biomedical Co. JIX Class II 1999-12-27
K983860 MTM BIOSCANNER K TEST STRIPS, CAT # BSA610 Polymer Technology Systems, Inc. JMK Class I 1999-12-27
K993771 CARESIDE DIRECT BILIRUBIN Careside, Inc. CIG Class II 1999-12-27
K994145 VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS Ortho-Clinical Diagnostics, Inc. JIS Class II 1999-12-22
K992232 FIRST RESPONSE 1-STEP PREGNANCY Armkel, LLC LCX Class II 1999-12-21
K993107 BIO-RAD HOMOCYSTEINE BY HPLC Bio-Rad LPS Class II 1999-12-21
K990258 QUANTECH TOTAL B-HCG ASSAY Quantech , Ltd. NAL Class II 1999-12-21
K992502 AXIS %CDT TURBIDIMETRIC IMMUNOASSAY Axis NAO Class I 1999-12-21
K993096 PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONITOR Lifestream Technologies, Inc. CHH Class I 1999-12-20
K981915 TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATION The Binding Site, Ltd. JJY Class I 1999-12-20
K993571 BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12 Bayer Corp. CDD Class II 1999-12-16
K993468 WAKO L-TYPE GOT TEST Wako Chemicals USA, Inc. CIT Class II 1999-12-16
K993837 AVL OPTI CRITICAL CARE ANALYZER Avl Scientific Corp. CGA Class II 1999-12-16
K993333 CLEARPLAN EASY II HOME PREGNANCY TEST Unipath , Ltd. LCX Class II 1999-12-16
K992939 QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3 Seracare Technology JJY Class I 1999-12-09
K993829 ACCU-CHEK SIMPLICITY SYSTEM Roche Diagnostics Corp. LFR Class II 1999-12-09
K993631 QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2 Seracare Technology JJY Class I 1999-12-09
K993309 BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAY Bayer Corp. MMI Class II 1999-12-06
K993353 TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM) Bayer Corp. MMI Class II 1999-12-06
K993634 CARESIDE ANALYZER Careside, Inc. JJF Class I 1999-12-02
K993703 CLEARVIEW EASY HCG PREGNANCY TEST Unipath , Ltd. JHI Class II 1999-12-02
K993317 ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE) ACON Laboratories, Inc. JHI Class II 1999-12-01
K993203 ACON ONE STEP PREGNANCY TEST STRIP (URINE) ACON Laboratories, Inc. JHI Class II 1999-12-01
K993310 APOLIPOPROTEIN CONTROL SERUM CHD, MODEL OUPH Dade Behring, Inc. JJY Class I 1999-11-30
K993546 TRI-POINT, LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL, LEVELS 1, 2, AND 3 Medical Analysis Systems, Inc. JJY Class I 1999-11-30
K993642 ELECSYS PARATHYROID HORMONE CALCHECK Roche Diagnostics Corp. JJX Class I 1999-11-30
K993606 K-ASSAY APO A1/B CALIBRATOR SET Kamiya Biomedical Co. JIX Class II 1999-11-26
K993014 MODIFICATION TO DOCUMENT THYROID CAL.VER Casco-Nerl Diagnostics Corporation (Maine) JJY Class I 1999-11-26
K992844 HICHEM ISE ELECTROLYTE BUFFER Elan Holdings, Inc. JGS Class II 1999-11-26
K981914 TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION The Binding Site, Ltd. JJX Class I 1999-11-26
K992842 HICHEM ISE ELECTROLYTE REFERENCE Elan Holdings, Inc. JGS Class II 1999-11-26
K993023 SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS Beckman Coulter, Inc. JJY Class I 1999-11-26
K992257 NEW MULTIPLES REAGENT STRIPS Bayer Corp. JIR Class I 1999-11-24
K992834 GEM PREMIER 3000 Instrumentation Laboratory CO CHL Class II 1999-11-24
K992710 ABBOTT ARCHITECH GLYCATED HEMOGLOBIN MASTERCHECK Abbott Laboratories JJY Class I 1999-11-24
K993360 PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA Roche Diagnostics Corp. JJY Class I 1999-11-24
K991417 ABL 735 ANALYZER Radiometer America, Inc. CHL Class II 1999-11-24
K992900 PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA Roche Diagnostics Corp. JJY Class I 1999-11-24
K993723 CARDIASURE CARDIAC MARKERS CONTROL Quantimetrix Corp. JJT Class I 1999-11-23
K993128 HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER] Health Hero Network, Inc. CGA Class II 1999-11-23
K992915 ONE-STEP DOUBLE-CHEK PREGNANCY TEST Biomedical Products Corp. JHI Class II 1999-11-18
K993251 IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6 Diagnostic Products Corp. LIG Class II 1999-11-17
K993715 QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3 Seracare Technology JJT Class I 1999-11-16
K993632 FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM Selfcare, Inc. CGA Class II 1999-11-12

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