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Clinical Chemistry

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

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RecordFirmDate
ELECSYS LH ASSAY (K964694)Boehringer Mannheim Corp.1997-01-24
HCL - 200 BIOCHEMISTRY ANALYZER (K964409)Hcl Laboratory Systems, Inc.1997-01-22
SEALITE SCIENCES, INC. AQUALITE LH (K964925)Sealite Sciences, Inc.1997-01-22
GLUCOMETER DEX DIABETES CARE SYSTEM (K963500)Bayer Corp.1997-01-21
AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST (K964574)Athena Medical Corp.1997-01-21
SAS ONE-STEP PREGNANCY (K964995)Sa Scientific, Inc.1997-01-21
ELECSYS PROLACTIN ASSAY (K964748)Boehringer Mannheim Corp.1997-01-21
AST/SGOT (K965126)Derma Media Lab., Inc.1997-01-17
SIGMA DIAGNOSTICS GLUCOSE REAGENT (K963535)Sigma Diagnostics, Inc.1997-01-17
N RHEUMATOLOGY STANDARD SL (K964527)Behring Diagnostics, Inc.1997-01-15
OLYMPUS LIPASE REAGENT (K963424)Olympus America, Inc.1997-01-14
AIA-PACK B12 ASSAY (K964348)Tosoh Medics, Inc.1997-01-13
LIQUICHEK URIANLYSIS CONTROL (CAT. NO. 420,421,422,425,426) (K965171)Bio-Rad1997-01-13
ROCHE COBAS IBTEGRA REAGENT CASSETTES (K964457)Roche Diagnostic Systems, Inc.1997-01-13
REP 3 QUTO-FLUR CHOLESTEROL-30 (K962914)Helena Laboratories1997-01-13
GAMMA-GLUTAMYL TRANSPEPTIDASE (K964916)Derma Media Lab., Inc.1997-01-10
LACTATE DEHYDROGENASE (K964912)Derma Media Lab., Inc.1997-01-09
VIDAS PROESTERONE (PRG) (30 409) (K965084)bioMerieux, Inc.1997-01-09
STC AUTO-LYTE URINARY GLUCOSE ASSAY (K962435)OraSure Technologies, Inc.1996-12-26
MODEL 5500 CEAS (K963938)Esa, Inc.1996-12-26
UREA NITROGEN (BUN) LIQUI-UV (K962418)Stanbio Laboratory1996-12-26
NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE (K962601)Nichols Institute Diagnostics1996-12-24
WAKO DIRECT HDL-C (K963847)Wako Chemicals USA, Inc.1996-12-24
BRIO AUTOMATIC SAMPLINC UNIT (K961209)Seac S.R.L.1996-12-24
REP 3 FLUR SPE-60 KIT (K964453)Helena Laboratories1996-12-23
REP FLUR CHOLESTEROL-60 KIT (K964471)Helena Laboratories1996-12-23
SYNERMED DIRECT BILIRUBIN REAGENT KIT (K963939)Synermed, Inc.1996-12-18
VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005) (K964721)Johnson & Johnson Clinical Diagnostics, Inc.1996-12-18
ELECSYS FSH ASSAY (K964693)Boehringer Mannheim Corp.1996-12-16
ELECSYS CALCHECK FSH (K964829)Boehringer Mannheim Corp.1996-12-16
VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001) (K964558)Johnson & Johnson Clinical Diagnostics, Inc.1996-12-16
ELECSYS FT3 (K963127)Boehringer Mannheim Corp.1996-12-16
SIGMA DIAGNOSTICS WASH CONCENTRATE (K963539)Sigma Diagnostics, Inc.1996-12-16
ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329 (K963934)Bio-Rad Laboratories, Inc.1996-12-16
ELECSYS CALCHECK LH (K964830)Boehringer Mannheim Corp.1996-12-16
CANTROL IRON/TIBC CONTROLS, LEVEL 1 AND LEVEL 2 PRODUCT NUMBERS: LEVEL 1: IIBC-91 AND LEVEL 2: IIBC-92 (K964640)Canyon Diagnostics, Inc.1996-12-13
PORPHOBILINOGEN (PBG) (K961984)Trace America, Inc.1996-12-10
NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE KIT (K962598)Nichols Institute Diagnostics1996-12-10
CLINICAL BLOOD GAS MIXTURES (K964475)Oxarc, Inc.1996-12-06
BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CONTROLS (K963770)Biocircuits Corp.1996-12-05
EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST (K963231)Excel Scientific, Inc.1996-12-04
FERRITIN CALIBRATOR (K963493)Dade Chemistry Systems, Inc.1996-12-03
MIDSTREAM ONESTEP PREGNANCY HOME TEST (K963341)Syntron Bioresearch, Inc.1996-12-02
ENZYMUN-TEST FT3 (K962760)Boehringer Mannheim Corp.1996-11-29
EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER (K963763)Medica Corp.1996-11-29
CAPILLARY ADAPTOR ACCESSORY (K963992)Medica Corp.1996-11-29
OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST (K963693)Princeton BioMeditech Corp.1996-11-29
WATERS 515 HPLC PUMP (515) (K964588)Waters Corporation1996-11-29
AVL COMPACT 3 PH/BLOOD GAS ANALYZER (K963964)Avl Scientific Corp.1996-11-29
AIA-PACK FOLATE ASSAY (K964349)Tosoh Medics, Inc.1996-11-27
VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010) (K964310)Johnson & Johnson Clinical Diagnostics, Inc.1996-11-27
EASYLYTE CALCIUM/CHLORIDE ANALYZER (K963694)Medica Corp.1996-11-27
VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025) (K964308)Johnson & Johnson Clinical Diagnostics, Inc.1996-11-27
CONTRAST STRIP HCG (K964156)Genzyme Diagnostics1996-11-25
CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST (K964155)Genzyme Diagnostics1996-11-25
PARAMAX AMMONIA AND AMMONIA BLANK REAGENT (K964565)Dade Intl., Inc.1996-11-22
WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6 (K964278)Clinical Controls, Inc.1996-11-22
N PROTEIN STRANDARD SL (K964062)Behring Diagnostics, Inc.1996-11-21
RDI LDL PRECIPITATION REAGENT (K964063)Reference Diagnostics, Inc.1996-11-20
RDI LIPIDIRECT MAGNETIC LDL REAGENT (K964064)Reference Diagnostics, Inc.1996-11-20
MINI STRIP/SERUM HCG (K963132)International Newtech Development, Inc.1996-11-18
TOTAL IRON (NITRO-PAPS) REAGENT SET (K961588)Pointe Scientific, Inc.,1996-11-18
PS-UNIT CASSETTE/SERUM HCG (K963133)International Newtech Development, Inc.1996-11-18
BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS (K961566)Biocircuits Corp.1996-11-18
FACT PLUS PREGNANCY TEST (K964108)Direct Access Diagnostics1996-11-18
IL SYNTHESIS (K963800)Instrumentation Laboratory CO1996-11-13
HEMOCUE GLUCOLIN (K963909)Direct Solutions1996-11-08
AIA-PACK FT3 ASSAY (K963687)Tosoh Medics, Inc.1996-11-08
PRESTIGE BLOOD GLUCOSE MONITORING SYSTEM,METER,TEST STRIPS & PRESTIGE HIGH AND LOW GLUCOSE CONTROL (K960855)Home Diagnostics, Inc.1996-11-07
NATURALE HCG PREGNANCY TES (K964002)Mizuho USA, Inc.1996-11-07
CARDIAC STATUS TROPONIN I (K963513)Princeton BioMeditech Corp.1996-11-07
N/T PROTEIN CONTROL SL (K964065)Behring Diagnostics, Inc.1996-11-06
ANTHOS PHACTS VERSION MICROPLATE READER (K962113)Columbia Bioscience, Inc.1996-11-05
ACS CORTISOL IMMUNOASSAY (K962559)Ciba Corning Diagnostics Corp.1996-11-05
ALPCO/MERCODIA INSULIN ELISA (K963911)American Laboratory Products Co., Ltd.1996-11-01
HEMOCUE GLUCOTROL (K964053)Direct Solutions1996-11-01
COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS (K963292)Roche Diagnostic Systems, Inc.1996-10-31
SIGMA DIAGNOSTICS CX -3 CALIBRATION STANDARD, LEVEL 2 (K963543)Sigma Diagnostics, Inc.1996-10-30
IMX FREE TRIIODOTHYRONINE (FREE T3) (K963833)Abbott Laboratories1996-10-30
AXSYM FREE TRIIODOTHYRONINE (FREE T3) (K963827)Abbott Laboratories1996-10-30
PICO MODELS 30, 50, 70 (K962158)Radiometer America, Inc.1996-10-29
MINI SAMPLE PROCESSOR (K962859)Cavro Scientific Instruments, Inc.1996-10-29
CEDIA CARDIAC TDM MULTI-CALS (K962269)Boehringer Mannheim Corp.1996-10-29
SIGMA DIAGNOSTIC CX -3 CALIBRATION STANDARD LEVEL 1 (K963533)Sigma Diagnostics, Inc.1996-10-29
RADIAS GALT TEST (K961432)Bio-Rad1996-10-28
GLUCOSE (HEXOKINASE) KIT (K953210)Randox Laboratories, Ltd.1996-10-25
RAPID ELECTROPHORESIS ANALYZER (K960571)Helena Laboratories1996-10-25
SIGMA DIAGNOSTICS CO2 ACID REAGENT (K963541)Sigma Diagnostics, Inc.1996-10-24
SIGMA DIAGNOSTICS BUN REAGENT (K963537)Sigma Diagnostics, Inc.1996-10-24
ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS (K963734)Alko Diagnostic Corp.1996-10-24
EML105 ELECTROLYTE METABOLITE ANALYZER (K962334)Radiometer America, Inc.1996-10-24
(MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE (K963627)Roche Diagnostic Systems, Inc.1996-10-24
CSF/URINE TOTAL PROTEIN (K961864)Teco Diagnostics1996-10-24
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL (K963213)Boehringer Mannheim Corp.1996-10-23
SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT (K962931)Smiths Industries Medical Systems, Inc.1996-10-21
VITROS IMMUNODIAGNOSTIC SYSTEM (K962919)Johnson & Johnson Clinical Diagnostics, Inc.1996-10-18
VISUALINE D HCG (K963408)Sun Biomedical Laboratories, Inc.1996-10-18
MICRO HAEMATOCRIT CENTRIFUGE (K960491)Hawksley & Sons , Ltd.1996-10-18
ISOLAB'S T4 TEST KIT (K951014)Isolab, Inc.1996-10-18
HEMOCUE B-GLCOSE SYSTEM (K962415)Hemocue, Inc.1996-10-15
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