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Clinical Chemistry

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

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RecordFirmDate
ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC) (K890997)Atlantic Wholesale, Inc.1989-03-28
COTUBE(TM) TSH IRMA (K890802)Bio-Rad1989-03-28
KODAK EKTACHEM 500 ANALYZER (K890928)Eastman Kodak Company1989-03-28
MAGNESIUM REAGENT (K891355)Medical Analysis Systems, Inc.1989-03-28
KODAK EKTACHEM 750 SERIES ANALYZER (K890929)Eastman Kodak Company1989-03-28
QMS(TM) - THEOPHYLLINE (K885263)Seradyn, Inc.1989-03-28
VENTREX COATED TUBE HCG (K890549)Ventrex Laboratories, Inc.1989-03-28
TECHNICON DAX(TM) SYSTEM (K885203)Technicon Instruments Corp.1989-03-28
KODAK EKTACHEM 500/750 SERIES ANALYZER, SOFT V1.0 (K890927)Eastman Kodak Company1989-03-28
GAMMA-GLUTAMYLTRANSFERASE (K890312)American Monitor Corp.1989-03-24
ABBOTT CLINICAL CHEMISTRY REAGENT ALP (K890521)Abbott Laboratories1989-03-24
ABBOTT OVULATION PREDICTOR TEST (K890510)Abbott Laboratories1989-03-24
KENLOR TOTAL IRON, UIBC/TIBC ASSAY KIT (K890573)Kenlor Industries, Inc.1989-03-24
STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES (K890908)Baxter Healthcare Corp1989-03-24
IQ/QCA PHOSPHORUS (K891218)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-03-22
COBAS MFC (K885292)Roche Diagnostic Systems, Inc.1989-03-22
BIOTROL URINE PROTEINS REAGENT (K890846)Biotrol, USA, Inc.1989-03-21
AMERLITE REPRODUCTIVE ENDOCRINOLOGY (LABEL CHANGE) (K890708)Amersham Corp.1989-03-20
DMA MICROPROTEIN PROCEDURE (K890868)Data Medical Associates, Inc.1989-03-20
EIA READER MODEL EL301 (K890854)Bio-Tek Instruments, Inc.1989-03-16
IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE) (K890609)Intl. Immunoassay Laboratories, Inc.1989-03-16
RIA-GNOST PROGESTERONE (K890836)Cambridge Medical Technology1989-03-16
SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B (K891154)Atlantic Antibodies1989-03-16
TSH MICROASSAY (K890579)Diamedix Corp.1989-03-16
RECONDITIONED ASTRA (TM) 8 (K883298)Associated Electro-Medical Services, Inc.1989-03-16
RECONDITIONED ASTRA(TM) 4 (K883350)Associated Electro-Medical Services, Inc.1989-03-16
RADIOASSAY CONTROLS 19,20,21,33,34 & 35 (QAS.109) (K890414)Amersham Corp.1989-03-15
APEC GLUCOSE ANALYZER (K890524)Amdev, Inc.1989-03-15
PG-NUMERIC(TM) (K883411)Isolab, Inc.1989-03-15
RIATRAC PLUS (K890470)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-03-15
IMPRES-MB REAGENT A AND REAGENT B (K890543)Intl. Immunoassay Laboratories, Inc.1989-03-13
PROGENE MICROALBUMINURIA SCREEN (K882538)Progene Corp.1989-03-13
LIPASE SR LIQUID STABLE REAGENT SET (K885078)Medical Analysis Systems, Inc.1989-03-13
HI CHEM CALIBRATION STANDARDS LEVELS 1 AND 2 (K890583)Hichem Diagnostics1989-03-13
HI CHEM WASH CONCENTRATE REAGENT #88805 (K890578)Hichem Diagnostics1989-03-10
CLINISTAT CHOLESTEROL REAGENT TEST (K884757)Heraeus Kulzer, Inc.1989-03-10
TRIGLYCERIDES - GPO REAGENT (K890337)Alpkem Corp.1989-03-09
TOTAL PROTEIN REAGENT (K890278)Sigma Chemical Co.1989-03-09
TARGET(TM) QUANTITATIVE HCG (K890131)V-Tech, Inc.1989-03-09
KENLOR LIQUID URINE CONTROL (K890577)Kenlor Industries, Inc.1989-03-09
KENLOR HUMAN SPINAL FLUID CONTROL LIQUID (K890576)Kenlor Industries, Inc.1989-03-09
DELFIA HLH SPEC KIT (K883814)Pharmacia, Inc.1989-03-08
BIOTROL IRON REAGENT (K890395)Biotrol, USA, Inc.1989-03-08
ALKALINE PHOSPHATASE ISOENZYME REAGENTS (K890269)Beckman Instruments, Inc.1989-03-08
ESTRADIOL MAIACLONE RADIOIMMUNOASSAY KIT (K890645)Serono-Baker Diagnostics, Inc.1989-03-08
MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1 (K890534)Fisher Scientific Co., LLC1989-03-08
SHAPE-ACTIO URINALYSIS CONTROLS (K890442)Actio, Inc.1989-03-08
ASPARTATE AMINOTRANSFERASE (AST) (K884724)Catachem, Inc.1989-03-08
C&T PREGNANCY TEST KIT (K884489)Healthcheck Corp.1989-03-08
TOTAL PROTEIN REAGENT (K890317)Medical Analysis Systems, Inc.1989-03-08
DELFIA SHBG KIT (K884809)Pharmacia, Inc.1989-03-08
STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBE (K890669)Norfolk Scientific, Inc.1989-03-08
TOTAL BILIRUBIN REAGENT, CONCENTRATED (K890070)Trace Scientific , Ltd.1989-03-06
MICROLITE TUBE LUMINOMETER #011-902-0000 (K890502)Dynatech Laboratories, Inc.1989-02-27
GLUCOSE (GOD) REAGENT (K890336)Alpkem Corp.1989-02-27
MODIFIED FREE T4 RADIOIMMUNOASSAY KIT (K884753)Advanced Magnetics, Inc.1989-02-27
ABBOTT CLINICAL CHEMISTRY REAGENT CK-NAC (K890540)Abbott Laboratories1989-02-27
DACOS OR DACOS XL CLINICAL CHEMISTRY ANALYZER (K884378)Coulter Corp.1989-02-27
CALCIUM PLUS PROCEDURE (K890302)Data Medical Associates, Inc.1989-02-27
17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA (K885198)Icn Biomedicals, Inc.1989-02-23
THYROXINE MICROASSAY (K884260)Diamedix Corp.1989-02-23
TITAN GEL ALKALINE PHOSPHATASE (HR) (K885341)Helena Laboratories1989-02-23
DELFIA PROGESTERONE KIT (K890428)Pharmacia, Inc.1989-02-23
SAFEPETTE DISPENSER (K890109)Safe-Tec Clinical Products, Inc.1989-02-23
DSL 7800 ACTIVE CORTISOL (K884689)Diagnostic Systems Laboratories, Inc.1989-02-23
CREATINE KINASE MB ENZYME IMMUNOASSAY KIT (K884550)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-02-23
CHOLESTEROL TEST ITEM NUMBER: SR1011 (K885023)Em Diagnostic Systems, Inc.1989-02-17
SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU. (K890335)Alpkem Corp.1989-02-17
RFA/2 RAPID FLOW ANALYZER W/COMPUTER (K890332)Alpkem Corp.1989-02-17
BICARBONATE TEST ITEM NUMBER: SR1006 (K890305)Em Diagnostic Systems, Inc.1989-02-17
ACA THYROXINE (T4 E) METHOD (K885258)The DU Pont Co.1989-02-17
MICROLITE CAMERA LUMINOMETER CL 1050 (0119010000) (K884782)Dynatech Laboratories, Inc.1989-02-17
HDL CHOLESTEROL REAGENT (PTA/MGCL2) (K890023)Sigma Diagnostics, Inc.1989-02-17
AMYLASE SR LIQUID STABLE REAGENT SET (K885176)Medical Analysis Systems, Inc.1989-02-17
BIOTROL CHLORIDE (K890015)Biotrol, USA, Inc.1989-02-17
ALKALINE PHOSPHATASE ISOENZYME SYSTEM (K885024)Ciba Corning Diagnostics Corp.1989-02-17
TECHNICON AXON(TM) SYSTEM (K885226)Technicon Instruments Corp.1989-02-17
EMIT THYROXINE ASSAY (K885141)Syva Co.1989-02-17
ACA THYRONINE UPTAKE (TU E) METHOD (K885259)The DU Pont Co.1989-02-17
AIR DISPLACEMENT PIPETTE (K885340)Ulster Scientific, Inc.1989-02-14
HDL CHOLESTEROL TEST (K885265)Em Diagnostic Systems, Inc.1989-02-10
CREATINE KINASE-MB TEST (CK-MK) ITEM NUMBER 65673 (K884547)Em Diagnostic Systems, Inc.1989-02-10
IMX FOLLICLE STIMULATING HORMONE (FSH) (K890135)Abbott Laboratories1989-02-10
IL PHOENIX, MODEL 900, CHEMISTRY/ELECTROLYTE ANALY (K884771)Instrumentation Laboratory CO1989-02-10
VENTREX COATED TUBE HIGH SENSITIVITY TSH (K885157)Ventrex Laboratories, Inc.1989-02-10
BIOTROL ALBUMIN (K885094)Biotrol, USA, Inc.1989-02-10
CLINISTAT TRIGLYCERIDES REAGENT TEST (K885134)Heraeus Kulzer, Inc.1989-02-10
IRON REAGENTS ITEM NUMBER: SR1017 (K890304)Em Diagnostic Systems, Inc.1989-02-10
PLASMA 40 INDUCT. COUPLED PLASMA EMMISSION SPECTRO (K884864)The Perkin-Elmer Corp.1989-02-10
AMERLITE FT3 ASSAY, LAN.0007/2007 240/144 TEST KIT (K885195)Amersham Corp.1989-02-08
HIGH VOLUME PROFILER & DATA ENHANCEMENT PACKAGE (K885288)Eastman Kodak Company1989-02-07
MODIFIED INTENDED USE OF CLEANING REAGENT KIT (K890184)Hichem Diagnostics1989-02-07
OLYMPUS TRIGLYCERIDES REAGENTS #SR1021 (K885266)Em Diagnostic Systems, Inc.1989-02-07
STANBIO MAGNESIUM TEST SET, CAT. NO 0130 (K883170)Stanbio Laboratory1989-02-07
MODIFIED INTENDED USE ON CLEANING NEUTRALIZER SOL. (K890183)Hichem Diagnostics1989-02-07
KODAK EKTACHEM 700 ANALYZER FAMILY, SOFT V5.0 (K885289)Eastman Kodak Company1989-02-07
PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY) (K890034)American Monitor Corp.1989-02-03
LYTENING 6 SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ (K884731)Amdev, Inc.1989-02-03
OLYMPUS ISE MODULE (K885193)Olympus Corp.1989-02-03
T-UPTAKE MICROASSAY (K885034)Diamedix Corp.1989-02-02
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