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Clinical Chemistry

13,051 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
RAICHEM PHOSPORUS REAGENT (K003012)Hemagen Diagnostics, Inc.2000-10-25
MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER (K002613)Nova Biomedical Corp.2000-10-19
INVERNESS MEDICAL OVULATION PREDICTOR TEST (K002867)Selfcare, Inc.2000-10-12
BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER (K002855)Biocare Corp.2000-10-12
VACUETTE WITH PPACK (K002777)Greiner Vacuette North America, Inc.2000-10-05
ELECSYS DHEA-S CALSET (K002760)Roche Diagnostics Corp.2000-10-05
REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105) (K001603)Repromedix Corp.2000-10-05
I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 (K001387)I-Stat Corp.2000-10-05
REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107) (K001606)Repromedix Corp.2000-10-05
N PROTEIN STANDARD SL (K002804)Dade Behring, Inc.2000-10-05
REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104) (K001607)Repromedix Corp.2000-10-05
BIOCHECK TESTOSTERONE EIA, MODEL BC-1115 (K002294)Biocheck, Inc.2000-10-02
CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80 (K002354)Diagnostic Chemicals , Ltd.2000-09-26
ATAC PAK ALP REAGENT KIT (K002285)Elan Diagnostics2000-09-26
LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578 (K002865)Bio-Rad2000-09-25
LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574 (K002866)Bio-Rad2000-09-25
BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD GLUCOSE TEST STRIP SYSTEMS (K002540)Bionostics, Inc.2000-09-18
UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30 (K002694)Diagnostic Chemicals , Ltd.2000-09-15
ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS) (K002290)Radiometer Medical A/S2000-09-13
CAMIT DIABETES MANAGEMENT SOFTWARE (K001907)Roche Diagnostics Corp.2000-09-05
LIQUICHEK LIPIDS CONTROL, MODEL 641, 642 (K002460)Bio-Rad2000-08-31
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER) (K002536)Bio-Rad2000-08-30
LIQUICHEC BLOOD GAS PLUSE CONTROL WITH GLUCOSE, MODEL 511, 512, 513 (K002535)Bio-Rad2000-08-30
CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY (K001943)Sangui Biotech, Inc.2000-08-23
ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565 (K001935)Beckman Coulter, Inc.2000-08-22
ELECSYS HCG TEST SYSTEM (K002148)Roche Diagnostics Corp.2000-08-22
DOCUMENT ASSAYED CHEMISTRY CONTROL, LEVELS 1, 2 AND3 (K002174)Casco-Nerl Diagnostics Corporation (Maine)2000-08-22
LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573 (K002120)Bio-Rad2000-08-21
WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG056 (K001411)Scantibodies Laboratory, Inc.2000-08-21
URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING (K001810)Flexsite Diagnostics, Inc.2000-08-14
SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P (K001403)Sigma Diagnostics, Inc.2000-08-10
ELECSYS CA 15-3 CALCHECK (K002353)Roche Diagnostics Corp.2000-08-10
ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM (K002134)Selfcare, Inc.2000-08-07
LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483 (K002196)Bio-Rad2000-08-07
STATLYTE NA/K/CL/LI ANALYZER (K001761)Nova Biomedical Corp.2000-08-07
HDL CHOLESTEROL PLUS (K000568)Roche Diagnostics Corp.2000-08-04
INVERNESS MEDICAL EARLY PREGNANCY TEST (K002049)Selfcare, Inc.2000-07-27
GENERIC BLOOD GLUCOSE TEST STRIP (K001092)Inbios Intl., Inc.2000-07-26
RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY (K001032)Otsuka Pharmaceutical Co., Ltd.2000-07-24
ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY (K993706)Roche Diagnostics Corp.2000-07-24
RESOLUTION CHOLESTEROL MONITOR (K000610)Lifestream Technologies, Inc.2000-07-21
VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 (K001885)Ortho-Clinical Diagnostics, Inc.2000-07-20
ELECSYS INSULIN CALSET (K001906)Roche Diagnostics Corp.2000-07-13
DADE TRU-LIQUID MONI-TROL CHEMISTRY CONTROL LEVELS 1, MID, 2, AND S (ASSAYED) (K001758)Medical Analysis Systems, Inc.2000-07-05
BIOSCANNER TRIGLYCERIDES TEST STRIPS (K000586)Polymer Technology Systems, Inc.2000-07-03
EZ LDL CHOLESTEROL TEST SYSTEM (K993741)Sigma Diagnostics, Inc.2000-07-03
SUGAR CHEX ONE (K001443)Streck Laboratories, Inc.2000-06-29
ELECSYS INSULIN CALCHECK (K001846)Roche Diagnostics Corp.2000-06-28
VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3 (K001679)Ortho-Clinical Diagnostics, Inc.2000-06-28
INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568) (K001569)Sigma Diagnostics, Inc.2000-06-26
DBEST HCG 2 IU/ML TEST KIT (K001215)Ameritek, Inc.2000-06-22
VITROS CHEMISTRY PRODUCTS CREA DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT (K001769)Ortho-Clinical Diagnostics2000-06-21
OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009 (K001632)Avl Scientific Corp.2000-06-19
QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT (K000754)Quantase , Ltd.2000-06-19
CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; RINSE SOLUTION KIT, MODEL A943-838 (K001484)Alko Diagnostic Corp.2000-06-19
ABSOLUTE HCG PREGNANCY TEST (K000844)Mizuho USA, Inc.2000-06-16
DELFIA NEONATAL IRT KIT (K993697)Wallac OY2000-06-09
SYNCHRON CONTROL (K001458)Beckman Coulter, Inc.2000-06-02
MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM (K001427)Selfcare, Inc.2000-06-02
AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30 (K001285)Diagnostic Chemicals , Ltd.2000-06-02
WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR (K001004)Wako Chemicals USA, Inc.2000-06-01
ELECSYS ANTI-TPO CALCHECK (K001014)Roche Diagnostics Corp.2000-06-01
WAKO HDL-C/LDL-C CALIBRATOR (K001005)Wako Chemicals USA, Inc.2000-06-01
LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363 (K001373)Bio-Rad2000-05-25
ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS (K000958)Elan Holdings, Inc.2000-05-24
WAKO LIPASE CALIBRATOR (K001002)Wako Chemicals USA, Inc.2000-05-24
BIOSCANNER TRIGLYCERIDES TEST STRIPS (K991894)Polymer Technology Systems, Inc.2000-05-24
FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900 (K001086)Diagnostic Systems Laboratories, Inc.2000-05-18
THE CARDIAC READER SYSTEM (K000784)Roche Diagnostics Corp.2000-05-18
ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS (K000556)Elan Diagnostics2000-05-17
EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER (K000926)Medica Corp.2000-05-15
VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 (K001310)Ortho-Clinical Diagnostics, Inc.2000-05-05
CONNECT DATA MANAGEMENT SYSTEM (K994433)Abbott Diabetes Care, Inc.2000-05-05
DIRECT TIBC CALIBRATOR (K000783)Reference Diagnostics, Inc.2000-05-04
ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS (K000900)Elan Holdings, Inc.2000-05-02
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA (K001266)Ortho-Clinical Diagnostics, Inc.2000-05-02
DIRECT TIBC KIT (K000781)Reference Diagnostics, Inc.2000-05-02
ELECSYS THYROGLOBULIN CALCHECK (K001015)Roche Diagnostics Corp.2000-04-27
VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2 (K001133)Ortho-Clinical Diagnostics, Inc.2000-04-24
ASSAYED QCS 1,2, CAT. NOS. 970200, 970500 (K000875)Bio-Rad2000-04-20
URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100 (K000874)Bio-Rad2000-04-18
I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER (K001154)I-Stat Corp.2000-04-18
STAT PROFILE PHOX PLUS ANALYZER (K000895)Nova Biomedical Corp.2000-04-17
SPIFE CHOLESTEROL PROFILE KIT (K000603)Helena Laboratories2000-04-17
DRG AURICA ELISA TESTOSTERONE KIT (K000043)Drg Intl., Inc.2000-04-17
APPRAISE-CARDIO SAMPLE COLLECTION KIT (K993787)Osborn Group, Inc.2000-04-14
QUALITROL LIPID CONTROL, LEVELS 1 AND 2 (K000810)Consolidated Technologies of Wisconsin2000-04-13
SAMPLOK (K000777)Itl Corporation Pty, Ltd.2000-04-11
FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT (K000471)Future Diagnostics B.V.2000-04-11
BAYER ADVIA IMS SYSTEM (K993867)Bayer Corp.2000-04-10
RANDOX CALCIUM (K000375)Randox Laboratories, Ltd.2000-04-05
ARCHITECH AFP MASTERCHECK, MODEL 6C01-05 (K992781)Bio-Rad2000-04-05
WAKO L-TYPE UN TEST (K993925)Wako Chemicals USA, Inc.2000-04-03
RANDOX ALBUMIN (K000483)Randox Laboratories, Ltd.2000-03-31
ACCESS OSTASE IMMUNOENZYMETRIC ASSAY (K994278)Beckman Coulter, Inc.2000-03-28
SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS (K000600)Syva Co., Dade Behring, Inc.2000-03-27
ELECSYS CORTISOL CALCHECK (K000576)Roche Diagnostics Corp.2000-03-21
AVL OPTI R ANALYZER (K000103)Avl Scientific Corp.2000-03-20
ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER (K000716)Beckman Coulter, Inc.2000-03-20
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM (K000583)Selfcare, Inc.2000-03-17
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