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Clinical Chemistry

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

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RecordFirmDate
IN-VITRO DIAGNOSTIC REAGENT SET (K930074)Horizon Diagnostics, Inc.1993-05-11
SYNERMED CREATINE KINASE REAGENT KIT (K930932)Synermed, Inc.1993-05-11
CLEARVIEW HCG (K924673)Unipath , Ltd.1993-05-11
DELFIA(R) HGH KIT (K930484)Wallac OY1993-05-11
IMMULITE CORTISOL (K931409)Diagnostic Products Corp.1993-05-11
USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000 (K931227)U.S. Drug Testing, Inc.1993-05-06
OLYMPUS REPLY CLINICAL CHEMISTRY ANALYZER (K925935)Olympus Corp.1993-04-22
LD-1 CONTROL-LEVEL 1 & 2 (K930874)Cala Diagnostics1993-04-22
IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R (K930166)Em Diagnostic Systems, Inc.1993-04-21
RADIAS AUTOMATED IMMUNOASSAY SYSTEM (K930898)Bio-Rad1993-04-21
CARDIO REP CK ISOENZYME KIT - 3310 (K931050)Helena Laboratories1993-04-20
BECTON DICKINSON SIMULTRAC COMPONENT SYSTEM (K925842)Bd Becton Dickinson Vacutainer Systems Preanalytic1993-04-20
HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807 (K925551)Hichem Diagnostics1993-04-20
HI CHEM ELECTROLYTE BUFFER (K925612)Hichem Diagnostics1993-04-20
HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806 (K925550)Hichem Diagnostics1993-04-20
CKMB ISOENZYME CONTROL-LEVEL 1,2.3 (K930873)Cala Diagnostics1993-04-13
CKMB CONTROL - LEVEL 1,2,3 (K930875)Cala Diagnostics1993-04-13
CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305 (K930359)Helena Laboratories1993-04-12
OPUS SEROLOGY CONTROLS (K925703)Pb Diagnostics, Inc.1993-04-08
HEMOCARD HEMOGLOBIN E (K930070)Isolab, Inc.1993-04-08
BESURE PLUS/(MIDSTREAM) ONE STEP PREG HOME TEST (K930488)Syntron Bioresearch, Inc.1993-04-06
SAS(TM) MONOCLONAL HCG-SLIDE (K930609)Sa Scientific, Inc.1993-03-29
VISTA PROLACTIN ASSAY (K926386)Syva Co.1993-03-29
TRACE MICROPROTEIN REAGENT (K925794)Trace America, Inc.1993-03-29
CREATINE KINASE (CK) REAGENT SET (K930660)Pointe Scientific, Inc.,1993-03-29
ELECTROPHORESIS CONTROL LEVEL 1 (K925326)Seradyn, Inc.1993-03-26
PROCLINIC ONE-STEP DIPSTICK PREGNANCY TEST (K930014)Vanguard Biomedical Corp.1993-03-25
AUTOSTAT ANTI-DSDNA (K925783)Cogent Diagnotics , Ltd.1993-03-22
CIBA CORNING ACS HCG IMMUNOASSAY (K925277)Ciba Corning Diagnostics Corp.1993-03-19
DC-UIBC-CAL (K925877)Diagnostic Chemicals, Ltd. (Usa)1993-03-18
PRECISE PREGNANCY (K930640)Bd Becton Dickinson Vacutainer Systems Preanalytic1993-03-18
PRECISE(TM) HCG(URINE/SERUM) AND PRCISE(TM) PREG (K926356)Becton Dickinson Advanced Diagnostics1993-03-18
AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT (K926563)Bio-Chem Laboratory Systems, Inc.1993-03-18
NATIONAL SCREENING INSTITUTE MICRO-PLATE TSH ASSAY (K923532)Solarcare Technologies Corp,Inc.1993-03-12
CALIBRATION VERIFICATION KIT OR CVK (K924802)Radiometer America, Inc.1993-03-09
IMMULITE PROLACTIN (K925846)Diagnostic Products Corp.1993-03-05
OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP (K930185)Princeton Biomedix1993-03-04
AIA-PACK AFP CALIBRATION VERIFICATION TEST SET (K924860)Tosoh Medics, Inc.1993-03-04
ACCUMETER(R) CHOLESTEROL SELF-TEST (K914432)Chemtrak, Inc.1993-03-02
VACUPLUS TUBES WITH LAVANDER STOPPERS (K924362)Starplex Scientific, Inc.1993-03-01
QUANTIMETRIX URINALYSIS MICROSCOPICS CONTROL (K925256)Quantimetrix Corp.1993-03-01
VACUPLUS TUBES WITH GREY STOPPERS (K924364)Starplex Scientific, Inc.1993-03-01
ACCESS HTSH ASSAY (K925637)Bio-Rad Laboratories, Inc.1993-03-01
NAT. SCREENING INSTITUTE MICRO-PLATE FREE T4 ASSAY (K925649)Solarcare Technologies Corp,Inc.1993-03-01
VACUPLUS TUBES WITH GREEN STOPPERS (K924361)Starplex Scientific, Inc.1993-03-01
TRIODOTHYRONINE (TC) COATED TUBE RIA (K926345)Monobind1993-02-25
STAT PROFILE 9 ANALYZER (K924497)Nova Biomedical Corp.1993-02-23
CANCER ANTIGEN CONTROL (K924061)Polymedco, Inc.1993-02-23
EXPRESSO CARTRIDGE (K923316)Bio-Rad Laboratories, Inc.1993-02-23
SYSTEMATE PLUS CALIBRATOR (K925101)Em Diagnostic Systems, Inc.1993-02-23
HI CHEM ELECTROLYTE REFERENCE REAGENT (K925611)Hichem Diagnostics1993-02-23
NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL (K925906)Analytical Control Systems, Inc.1993-02-18
SYNERMED SINGLE REAGENT CREATININE KIT (K926511)Synermed, Inc.1993-02-18
VISTA(R) HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY (K926342)Syva Co.1993-02-17
TANDEM-E IGE II CALIBRATION VERIFICATION SET (K922754)Hybritech, Inc.1993-02-17
HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813 (K925553)Hichem Diagnostics1993-02-12
MINIVIDAS INSTRUMENT (K923579)Biomerieux Vitek, Inc.1993-02-12
HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812 (K925552)Hichem Diagnostics1993-02-12
SYNCHRON CX5CE CLINICAL ANALYZER (K926060)Beckman Instruments, Inc.1993-02-12
VIDAS ESTRADIOL (E2) ASSAY (K925498)Biomerieux Vitek, Inc.1993-02-12
OLYMPUS CHOLESTEROL REAGENT (K925603)Olympus Corp.1993-02-08
VACUPLUS(R) STAR-SEP(TM) (K924363)Starplex Scientific, Inc.1993-02-08
ACCESS TOTAL BHCG ASSAY (K926198)Bio-Rad Laboratories, Inc.1993-02-08
OLYMPUS ALBUMIN REAGENT (K924368)Olympus Corp.1993-02-08
OLYLMPUS ALANINE AMINOTRANSFERASE REAGENT (K925339)Olympus Corp.1993-02-05
KODAK AMERLITE CK-MB CONTROL SERA LAN.4413 (K925880)Eastman Kodak Company1993-02-05
LACTATE DEHYDROGENASE (LD) TEST ITEM #65418 (K924703)Em Diagnostic Systems, Inc.1993-02-05
ABBOTT QUICKSTART LD-1, MODIFICATION (K925188)Em Diagnostic Systems, Inc.1993-02-05
REFLAB SYSTEM PACK LIQUID CO2 REAGENT (K926320)Medical Analysis Systems, Inc.1993-02-03
IMMUCHEM LH-MW ELISA (K922944)Icn Biomedicals, Inc.1993-02-02
SAS ONE STEP PREGNANCY (K926204)Sa Scientific, Inc.1993-02-02
CHOLESTEROL TEST ITEM# 42374/93, 42322/R1 (K924508)Em Diagnostic Systems, Inc.1993-01-28
NOVA 8 CRT ANALYZER (K924547)Nova Biomedical Corp.1993-01-28
CLINITEK 200+ URINE CHEMISTRY ANALYZER (K926359)Heraeus Kulzer, Inc.1993-01-28
ISE CALIBRATOR FOR DUPONT DIMENSION (K926518)Alko Diagnostic Corp.1993-01-28
SUGAR CHEX LINEARITY FOR THE ONE TOUCH (K925479)Streck Laboratories, Inc.1993-01-28
POWER SUPPLY (K924021)The Binding Site, Ltd.1993-01-28
ROCHE COBAS FUTURA GLUCOSE (K922811)Roche Diagnostic Systems, Inc.1993-01-27
ACCESS(R) FREE T4 ASSAY (K925913)Bio-Rad Laboratories, Inc.1993-01-27
URINE MAGNESIUM METHOD FOR TECHNICON CHEM SYSTEMS (K926144)Heraeus Kulzer, Inc.1993-01-27
REFRACTROL-SP (K926095)Medical Specialties, Inc.1993-01-26
OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENT (K925337)Olympus Corp.1993-01-26
TRIGLYCERIDES (K924710)Em Diagnostic Systems, Inc.1993-01-26
OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT (K925155)Olympus Corp.1993-01-26
LIFESIGN HCG - ONE STEP HOME PREGNANCY TEST (K926308)Princeton Biomedix1993-01-26
MAXSOFTWARE (K925547)Diagnostic Products Corp.1993-01-26
ABBOTT IMX T4 (K925110)Abbott Laboratories1993-01-26
OLYMPUS URIC ACID REAGENT (K925113)Olympus Corp.1993-01-26
MICROPROTEIN REAGENT SET (K921412)Sterling Diagnostics, Inc.1993-01-21
PRO-STEP HCG (K925125)Disease Detection International, Inc.1993-01-13
IMX PAP (K925377)Abbott Laboratories1993-01-13
HDL-CHOLESTEROL STANDARD, MODIFICATION (K924904)Verichem Laboratories, Inc.1993-01-13
AIA-PACK PRL CALIBRATION VERIFICATION TEST SET (K924856)Tosoh Medics, Inc.1993-01-11
DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD (K924493)Casco Standards1993-01-11
ASIA-PACK TSH CALIBRATION VERIFICATION TEST SET (K924852)Tosoh Medics, Inc.1993-01-11
ACTIVE RENIN IMMUNORADIOMETRIC ASSAY (K925998)Nichols Institute Diagnostics1993-01-06
DIRECT LDL CHOLES IMMUNOSEPARATION REAGENT (K924674)Genzyme Corp.1993-01-06
PREGNAGEN 1-STEP PREGNANCY TEST (K925189)Biogenex Laboratories1993-01-06
DADE(R) CK-MB/MYOGLOBIN IMMUN CONTROL, I,II,III (K926046)Baxter Diagnostics, Inc.1993-01-05
ROCHE REAGENT FOR AST (K924244)Roche Diagnostic Systems, Inc.1993-01-04
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