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Clinical Chemistry

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

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RecordFirmDate
HDL PRECIPITATING REAGENT (K893966)Diagnostic Systems1989-07-25
STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010 (K893128)Stanbio Laboratory1989-07-25
ACID PHOSPHATASE REAGENT (K892393)Medical Analysis Systems, Inc.1989-07-20
MINICLINIC OVULATION PREDICTION TEST (K891762)Vanguard Biomedical Corp.1989-07-20
PANCREATIC A-AMYLASE PNP (K892848)Boehringer Mannheim Corp.1989-07-20
DADE LIPID-TROL (K893580)Baxter Healthcare Corp1989-07-20
J&S IRON SATURATING REAGENTS (K893662)J.S. Medical Assoc.1989-07-20
CENTRICON CONCENTRATOR (K893733)Amicon, Inc.1989-07-20
CIBA CORNING MODEL 570 ALLIANCE I.S.E. MODULE (K892500)Ciba Corning Diagnostics Corp.1989-07-20
ALANINE AMINOTRANSFERASE TEST (ALT) ITEM # 65403 (K893752)Em Diagnostic Systems, Inc.1989-07-20
TECHNICON AXON TM SYSTEM ADDITIONAL ANALYTES (K892929)Technicon Instruments Corp.1989-07-20
TOTAL BILIRUBIN FOR MANUAL/AUTOMATED APPLICATIONS (K892668)Catachem, Inc.1989-07-20
STAT CHEM SYSTEM (K891050)Diagnostic Resources, Inc.1989-07-20
ALT REAGENT (PROCEDURE NUMBER 159) (K893560)Sigma Chemical Co.1989-07-20
COBAS FARA CENTRIFUGAL ANALYZER (K893641)Roche Diagnostic Systems, Inc.1989-07-20
GAMMA GLUTAMYL TRANSFERASE TEST, ITEM: 65414/R1 (K893765)Em Diagnostic Systems, Inc.1989-07-20
REP(TM) CK-2 STAT KIT, CAT. NO. 3074 (K893007)Helena Laboratories1989-07-20
DOCUMENT(TM) URIC ACID LINEARITY TEST SET (K893139)Casco Standards1989-07-20
BECKMAN PARAGON(TM) CREATINE KINASE ISOENZYME (K893269)Beckman Instruments, Inc.1989-07-20
SERUMAX (AUTOMATED SERUM CENTRIFUGATION & STATION) (K893400)Medical Robotics1989-06-23
DOCUMENT(TM) TRIGLYCERIDE LINEARITY TEST SET (K893140)Casco Standards1989-06-23
DOCUMENT(TM) IRON MAGNESIUM LINEARITY TEST SET (K893141)Casco Standards1989-06-23
URIC ACID REAGENT (PROCEDURE NUMBER 686) (K893416)Sigma Chemical Co.1989-06-23
DOCUMENT(TM) IRON, MAGNES, TRIGLY LINEAR TEST SET (K893142)Casco Standards1989-06-23
BACTON TM, BASIC TM, APO B REAGENT (K893884)Catachem, Inc.1989-06-21
ACS COLLOID OSMOTIC PRESSURE CALIBRATOR (K892213)Analytical Control Systems, Inc.1989-06-21
DELTA (TM) ROBOTIC PIPETTOR (K893031)Diagnostic Products Corp.1989-06-21
AST REAGENT (PROCEDURE NUMBER 158) (K892844)Sigma Chemical Co.1989-06-20
ENZYMATIC UREA NITROGEN REAGENT SET (K892331)American Monitor Corp.1989-06-20
SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY (K893605)Serono-Baker Diagnostics, Inc.1989-06-20
IL1400, BGELECTROLYTE ANALYZER (K890827)Instrumentation Laboratory CO1989-06-20
REP(TM) LD-2 STAT KIT, CAT. NO. 3078 (K892818)Helena Laboratories1989-06-20
AMRESCO PRODUCT NUMBER 7426 (K891923)American Research Products Co.1989-06-20
BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST (K892654)Princeton Biomedix1989-06-19
CHOLESTEROL REAGENT SET (K893479)American Monitor Corp.1989-06-19
DIRECT BILIRUBIN FOR MANUAL OR AUTOMATED APPLI. (K892905)Catachem, Inc.1989-06-19
AMRESCO UREA NITROGEN (BUN) REAGENTS, PROD # 7123 (K891912)American Research Products Co.1989-06-19
REP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171 (K893211)Helena Laboratories1989-06-19
VIS-DISK HCG (EIA) JPL-041M (K891096)Leeco Diagnostics, Inc.1989-06-16
MICROTRAK EIA AUTOREADER (K891270)Syva Co.1989-06-16
AMRESCO CHOLESTEROL REAGENTS, PROD. # 7325 (K891922)American Research Products Co.1989-06-16
GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST (K893117)Bayer Corp.1989-06-16
D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN (K892224)Photec Diagnostics, Inc.1989-06-16
IRON SYSTEM PACK REAGENTS (K892838)Boehringer Mannheim Corp.1989-06-16
VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M (K891095)Leeco Diagnostics, Inc.1989-06-16
LYPHOCHEK TUMOR MARKER CONTROLS, LEVELS I AND II (K891680)Bio-Rad1989-06-13
NEOCHROME(R) III GLUCOSE (K892002)American Monitor Corp.1989-06-12
BICARBONATE; SYSTEM PACK REAGENTS (K891991)Boehringer Mannheim Corp.1989-06-09
ASSAYED CHOLINESTERASE CONTROL (K885282)Actio, Inc.1989-06-09
REP LIPO-8 KIT, NO. 3182/REP LIPO-16 KIT, NO. 3181 (K893223)Helena Laboratories1989-06-09
DIALBUMIN (K891544)Exocell, Inc.1989-06-09
SR1 (FSH) IMMUNOENZYMETRIC ASSAY (K892706)Serono-Baker Diagnostics, Inc.1989-06-09
LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030 (K891574)Em Diagnostic Systems, Inc.1989-06-09
CLA 200 CHEMPRO(R) LIPID ANALYZER (K892238)Johnson & Johnson Professionals, Inc.1989-06-07
EASY-TEST IRON (IRON) ITEM NO. 16686 (K892863)Em Diagnostic Systems, Inc.1989-06-07
AMRESCO URIC ACID REAGENTS #7628 (K892395)American Research Products Co.1989-05-24
HCG IRMA II (K891770)Pacific Biotech, Inc.1989-05-24
THE CDI(R) SYSTEM 400 (K890113)Cardiovascular Devices, Inc.1989-05-23
COOMASSIE BLUE TOTAL PROTEIN ASSAY KIT (K890618)Kenlor Industries, Inc.1989-05-22
ROCHE(R) CARDIOSCREEN-CK (K891462)Roche Diagnostic Systems, Inc.1989-05-22
AVL MODEL 987 ELECTROLYTE ANALYZER (K891578)Avl Scientific Corp.1989-05-22
AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT (K891468)Trace Scientific , Ltd.1989-05-22
DRI-DYE CHECK STRIPS (TM)-405 (K892656)Awareness Technology, Inc.1989-05-22
YSI MODEL 2300 STAT GLUCOSE AND L-LACTATE ANALYZER (K891480)Yellow Springs Instrument Co., Inc.1989-05-22
T4 CLASP-BEAD EIA KIT (K892853)Biotecx Laboratories, Inc.1989-05-22
THERMOMAX MICROPLATE READER, MODIFICATION (K892063)Molecular Devices Corp.1989-05-11
DIRECT BILIRUBIN FOR CONTINUOUS FLOW (K891240)Catachem, Inc.1989-05-10
CK-NAC 2-VIAL REAGENT W/SUBSTRATE START (K891470)Trace Scientific , Ltd.1989-05-09
CLS 962 MICROPLATE PHOTOMETER (K891869)Cambridge Life Sciences Plc.1989-05-09
MONI-TROL(R) (K891929)Baxter Healthcare Corp1989-05-09
HI CHEM CREATININE REAGENT (PRODUCT #88809) (K890671)Hichem Diagnostics1989-05-09
IQ ALBUMIN (K891375)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-05-05
LD1 ISOENZYME REAGENT KIT (K890996)Trace Scientific , Ltd.1989-05-05
ELECTRODE A.PH BLOOD GAS B.ELECTROLYTE SYSTEMS (K884267)Alko Diagnostic Corp.1989-05-04
TOTAL CHOLESTEROL REAGENT (K890334)Alpkem Corp.1989-05-03
POTASSIUM AND SODIUM ELECTROLYTE ANALYZER (K890792)Ionetics, Inc.1989-05-03
IQ CALCIUM (K891217)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-05-03
ADVANCED PURIFICATION GLASS COLUMN (K891673)Waters Chemical Products1989-04-26
DSL 7900 ACTIVE DHEA-S (DSL #7900) (K891478)Diagnostic Systems Laboratories, Inc.1989-04-26
QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD (K890027)Photec Diagnostics, Inc.1989-04-26
QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA (K890267)Photec Diagnostics, Inc.1989-04-26
RIA-GNOST INSULIN (K890837)Cambridge Medical Technology1989-04-26
MRI NEO-TRYP TRYPSIN RIA (K883011)Microbiological Research Corp.1989-04-26
IRON REAGENT (K891155)Medical Analysis Systems, Inc.1989-04-18
DIRECTIGEN1-2-3 BHCG PREGNANCY TEST (K890615)Quidel Corp.1989-04-18
HI CHEM INORGANIC PHOSPHORUS REAGENT KIT #88196 (K890773)Hichem Diagnostics1989-04-18
EMIT CONVENIENCE PACK: THYROXINE ASSAY (K890831)Syva Co.1989-04-14
URIC ACID KIT, CODES 4825400 AND 4825050 (K890319)American Research Products Co.1989-04-12
HDL CHOLESTEROL REAGENT (K891117)Pointe Scientific, Inc.,1989-04-10
BIOTROL CHEMISTRY URINE CONTROL (K891286)Biotrol, USA, Inc.1989-04-10
ABBOTT ALT-ACTIVATED (LIQUID, LIST #01A55) (K890698)Abbott Laboratories1989-04-10
HI CHEM CALCIUM REAGENT #88808 (K890584)Hichem Diagnostics1989-04-10
EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE (K890990)Hichem Diagnostics1989-04-10
VENTREX COATED TUBE T3 UPTAKE (K891068)Ventrex Laboratories, Inc.1989-04-10
TOTAL BILIRUBIN FOR CONTINUOUS FLOW (K891025)Catachem, Inc.1989-04-04
CHROMATOGRAPHY KIT (K884176)Gelman Sciences, Inc.1989-04-04
GLUCOFILM TEST STRIPS & CONTROLS/GLUCOMETER 3 (K890873)Heraeus Kulzer, Inc.1989-04-04
ALT (GPT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT (K891469)Trace Scientific , Ltd.1989-04-04
ROCHE CHLORIDE ELECTRODE (K890528)Roche Diagnostic Systems, Inc.1989-03-31
REVISED MAGNESIUM TEST ITEM NUMBER: SR1019 (K890798)Em Diagnostic Systems, Inc.1989-03-31
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