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Clinical Chemistry

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

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RecordFirmDate
ABBOTT SPECTRUM GLUCOSE-HEXOKINASE REAGENT (K894394)Abbott Laboratories1989-10-03
VISION WHOLE BLOOD HDL CHOLESTEROL (K895158)Abbott Laboratories1989-10-02
DELTATEST (R) LIPASE II (K893718)Electro-Nucleonics, Inc.1989-09-28
AMRESCO TRIGLYCERIDES REAGENTS (PRODUCTS 7730) (K894310)American Research Products Co.1989-09-28
TDXR ANALYZER WITH LITES TM LITHIUM CAROUSEL (K894222)Abbott Laboratories1989-09-28
SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED) (K894804)Lifescan, Inc.1989-09-28
FPR GENTAMICIN CALIBRATOR KIT (K894524)Colony Laboratories, Inc.1989-09-28
FPR AMIKACIN CALIBRATOR KIT (K894518)Colony Laboratories, Inc.1989-09-28
SERACHEM PLUS CLINICAL CHEMISTRY CONTROLS (K894852)Instrumentation Laboratory CO1989-09-28
ORTHO APO B ELISA TEST SYSTEM (K895277)Medical Marketing Consultants, Inc.1989-09-27
IMX TOTAL B-HCG (K894182)Abbott Laboratories1989-09-26
ABBOTT SPECTRUM(R) CALCIUM REAGENT (K894407)Abbott Laboratories1989-09-25
FPR PHENYTOIN CALIBRATOR KIT (K894528)Colony Laboratories, Inc.1989-09-25
FREE T3 RADIOIMMUNOASSAY KIT (K894200)Advanced Magnetics, Inc.1989-09-25
DELFIA FREE THYROXINE (FT4) KIT (K894605)Pharmacia, Inc.1989-09-18
MILENIA(TM) PROLACTIN (MKPR1,5) (K895003)Diagnostic Products Corp.1989-09-18
BIOTEL MICROALBUMINURIA (TM) (K894169)American Diagnostic Corp.1989-09-18
BICARBONATE TEST ITEM NUMBER: 65412 (K894509)Em Diagnostic Systems, Inc.1989-09-15
REP TM SPE (PONCEAU S) PROCEDURES (K894585)Helena Laboratories1989-09-13
ABBOTT AST-ACTIVATED (LIQUID, LIST#01A54) (K894180)Abbott Laboratories1989-09-13
TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT (K894761)Hybritech, Inc.1989-09-13
IMMUNOCOAT PROGESTERONE RADIOIMMUNOASSAY KIT (K894049)Pantex, Div. Bio-Analysis, Inc.1989-09-08
TRIGLYCERIDE (GPO) TRINDER REAGENT (K894063)Sigma Diagnostics, Inc.1989-09-07
PINSET (K884970)Safety Diagnostics, Inc.1989-09-07
NOVA NUCLEUS CLINICAL CHEMISTRY SYSTEM (K894218)Nova Biomedical Corp.1989-09-07
LACTATE DEHYDROGENASE TEST (LD) ITEM #65418 (K894482)Em Diagnostic Systems, Inc.1989-09-07
SAKURA PREP AI AUTOMATIC LIQUID HANDLING SYSTEM (K893811)Sakura Finetek U.S.A., Inc.1989-09-07
GLUCOSE-HK TEST (GLU-HK) ITEM #65415 (K894483)Em Diagnostic Systems, Inc.1989-09-07
DSL 17A-OH PROGERSTERONE (DSL #6800) (K894265)Diagnostic Systems Laboratories, Inc.1989-09-07
BUN-BLOOD UREA NITROGEN FOR MANUAL/AUTO APPLICAT (K894173)Catachem, Inc.1989-09-05
ABBOTT TESTPACK PLUS HCG URINE (K894408)Abbott Laboratories1989-09-05
GEMTAB SYSTEM (K894503)Pharmacia Eni Diagnostics, Inc.1989-09-05
ROCHE REAGENT FOR URIC ACID (K894101)Roche Diagnostic Systems, Inc.1989-09-05
CALCIUM TEST ITEM NUMBER: 65409 (K893778)Em Diagnostic Systems, Inc.1989-09-05
RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL (K894329)Amersham Corp.1989-09-05
EMIT T-UPTAKE ASSAY (K894145)Syva Co.1989-09-05
EMDS TOTAL PROTEIN (TP), ITEM NUMBER 65420 (K893915)Em Diagnostic Systems, Inc.1989-08-31
PHOSPHORUS TEST ITEM NUMBER 65416 (K894288)Em Diagnostic Systems, Inc.1989-08-31
DYNATECH MR 5000, CATALOG #011-976-0600 (K894687)Dynatech Laboratories, Inc.1989-08-31
QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT (K894057)Photec Diagnostics, Inc.1989-08-31
UREA NITROGEN TEST (BUN) ITEM #65408 (K894378)Em Diagnostic Systems, Inc.1989-08-31
EMDS CREATINE KINASE ITEM NIMBER 65411 (K893691)Diagnostic Systems1989-08-31
REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187 (K894366)Helena Laboratories1989-08-31
DPC-ROBOSTAT(TM) (K894710)Diagnostic Products Corp.1989-08-31
ROCHO ISOMUNE - LD (K894081)Roche Diagnostic Systems, Inc.1989-08-31
POSITIVE AND NEGATIVE HCG URINE CONTROLS (K894181)Armkel, LLC1989-08-31
MAGNESIUM TEST ITEM NUMBER: 65419 (K894508)Em Diagnostic Systems, Inc.1989-08-31
MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER (K893838)Ciba Corning Diagnostics Corp.1989-08-31
STATSPIN MINI-PLASMA (K893613)Statspin Technologies1989-08-28
CK-MB/LD-1 CONTROL SYSTEM (K894207)Boehringer Mannheim Corp.1989-08-28
EMDS TRIGLYCERIDE (TRIG), ITEM NUMBER 65421 (K893917)Em Diagnostic Systems, Inc.1989-08-28
EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410 (K893916)Em Diagnostic Systems, Inc.1989-08-28
URIC ACID TEST ITEM NUMBER 65422 (K894287)Em Diagnostic Systems, Inc.1989-08-28
SINGLE AND DUAL BAND DIPSTICK HCG TEST (K893873)Ampcor, Inc.1989-08-21
ABBOTT COMMANDER FLEXIBLE PIPETTING CENTER (K894069)Abbott Laboratories1989-08-21
DENLEY ANTHOS 2001 READER (K894270)Denley Instruments, Inc.1989-08-21
EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405 (K893692)Diagnostic Systems1989-08-21
LIQUID CHROMATOGRAPHY COLUMNS (K894141)Supelco, Inc.1989-08-21
ALBUMIN TEST (ALB) ITEM NUMBER: 65401 (K893777)Em Diagnostic Systems, Inc.1989-08-21
DENLEY WELLDILL 3 (K894272)Denley Instruments, Inc.1989-08-21
COAT-A-COUNT (TM) FSH IRMA (K893976)Diagnostic Products Corp.1989-08-17
AMYLASE TEST (AML) ITEM NUMBER: 65404 (K893751)Em Diagnostic Systems, Inc.1989-08-17
CHLORIDE STANDARDS ITEM #SR1041 (K891999)Em Diagnostic Systems, Inc.1989-08-15
ABSOLUTE(TM)-HCG URINE PREGNANCY TEST (K893953)Totem Diagnostics, Inc.1989-08-15
ROBOTIC SAMPLE PROCESSOR (K894126)Tecan U.S., Ltd.1989-08-15
CLINISTAT TOTAL BILIRUBIN REAGENT TEST (K892801)Heraeus Kulzer, Inc.1989-08-15
DENLEY WELLWASH 2 AND 4 (K894271)Denley Instruments, Inc.1989-08-15
ABBOTT SPECTRUM AMYLASE REAGENT (K891241)Abbott Laboratories1989-08-15
MODIFIED PK300 AUTOMATIC EIA ANALYZER (K893768)Olympus Corp.1989-08-15
AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT (K893469)Amersham Corp.1989-08-15
LUTEINIZING HORMONE MAB SOLID PHASE COMPONENT SYST (K894279)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-08-15
TARGET(TM) CK-MB (K890295)V-Tech, Inc.1989-08-15
T3 CLASP-BEAD EIA KIT (K893620)Biotecx Laboratories, Inc.1989-08-11
OLYMPUS ISE MODULE FOR AU5000 (K893628)Olympus Corp.1989-08-11
QUIDEL REFLECTANCE ANALYZER (K893738)Quidel Corp.1989-08-11
ROCHE REAGENT FOR TRIGLYCERIDES (K893973)Roche Diagnostic Systems, Inc.1989-08-11
DIRECT BILIRUBIN REAGENT (K893730)Medical Analysis Systems, Inc.1989-08-11
LYPHOCHEK(R) TUMOR MARKER CONTROLS, LEVELS I & II (K894078)Bio-Rad1989-08-11
EXCEL (TM) CHEMISTRY ANALYZER (K893137)American Monitor Corp.1989-08-10
BIOTROL CALCIUM MONOREACTIF (K891061)Biotrol, USA, Inc.1989-08-10
CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM (K892060)Syva Co.1989-08-10
PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI (K893508)Baxter Healthcare Corp1989-08-04
EMIT D.A.U. LOW & MEDIUM CALIBRATOR A (K894327)Syva Co.1989-08-03
OPUS IMMUNOASSAY SYSTEM (K894159)Pb Diagnostic Systems, Inc.1989-08-03
COBAS FARA II CENTRIFUGAL ANALYZER (K893854)Roche Diagnostic Systems, Inc.1989-08-03
ABBOTT ASSET AUTOMATED CLINICAL CHEMISTRY ANALYZER (K893776)Abbott Laboratories1989-08-03
STATUS HCG FLUOROMETRIC ENZYME (K893577)Baxter Healthcare Corp1989-08-03
IMMUNO-WASH AUTOMATED TUBE WASHER (K893810)Ocean Scientific, Inc.1989-08-03
SERALYZER HDL CHOLESTEROL PROCEDURE USE W/STRIP (K893548)Heraeus Kulzer, Inc.1989-08-03
QUALICHECK 2 (K894110)Radiometer America, Inc.1989-08-03
AMERLEX-MAB FT4 KIT (K894091)Amersham Corp.1989-08-03
INTEGRA(TM) BLOOD GLUCOSE MONITORING SYSTEM (K893404)Apprise, Inc.1989-08-03
CLINIMATE-TDA BLOOD CHEMISTRY ANALYZER (K893547)Heraeus Kulzer, Inc.1989-08-03
LYPHOCHEK IMMUNOASSAY PLUS CONTROL SERUM (K894252)Bio-Rad1989-08-01
LYPHOCHEK(R) IMMUNOASSAY CONTR SERUM (HUMAN) 1,2,3 (K891475)Bio-Rad1989-08-01
CIBA CORNING MAGIC LITE FOLATE IMMUNOASSAY (K893684)Ciba Corning Diagnostics Corp.1989-07-27
TECHNICON DAX TM SYSTEM ADDITIONAL ANALYTES (K892930)Technicon Instruments Corp.1989-07-27
DU PONT DIMENSION PSID CLINICAL CHEMISTRY SYSTEM (K893775)E.I. Dupont DE Nemours & Co., Inc.1989-07-25
GENETIC SYSTEMS MICROPLATE READER (K891767)Genetic Systems Corp.1989-07-25
MINICLINIC PREGNANCY TEST (K894012)Vanguard Biomedical Corp.1989-07-25
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