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Clinical Chemistry

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

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RecordFirmDate
RINSE & REFERENCE SOLUTION/BUFFER/LOW & HIGH STAN. (K882801)Hf Scientific, Inc.1988-08-29
EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95 (K882766)Em Diagnostic Systems, Inc.1988-08-23
MD STRIPS BG (K875049)Amatech International, Inc.1988-08-23
CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES (K882488)Canyon Diagnostics, Inc.1988-08-15
ABBOTT SPECTRUM SIMULSTAT GLUCOSE/BUN REAGENT (K882334)Abbott Laboratories1988-08-09
MONOJECT(R) SNAP-OVER SAFETY CAP (K882614)Sherwood Medical Co.1988-08-09
PROFILE ONE OMNI (K882559)Modular Diagnostic Systems, Inc.1988-08-08
A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM (K882586)A-Kem, Inc.1988-08-08
A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM (K882587)A-Kem, Inc.1988-08-08
CLEANTECH SYSTEM (K882539)Schiff & Co.1988-08-08
COTUBE HCG IRMA TEST (K882155)Bio-Rad1988-08-08
SOLID PHASE EXTRACTION TUBES (K881361)Supelco, Inc.1988-08-08
AMERLITE TOTAL THYROID CONTROL SERA LAN.4001 (K882727)Amersham Corp.1988-08-08
LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA (K882340)Serono Diagnostics, Inc.1988-08-08
MAGNESIUM REAGENT SET (K882256)Tech-Neal Scientific, Inc.1988-08-08
IMX CKMB (K883013)Abbott Laboratories1988-08-08
REP HDL ELECTROPHORESIS METHOD (K882368)Helena Laboratories1988-08-08
PHASE II LH KIT (K882252)Vitek Systems, Inc.1988-08-04
GEMINII GAMMA COUNTER (K882194)Laboratory Technologies, Inc.1988-08-04
VISION(R) TOTAL BILIRUBIN WITH A NEONATAL CLAIM (K880437)Abbott Laboratories1988-08-03
ENZYMATIC CO2 REAGENT SET (K882497)American Monitor Corp.1988-08-02
CALIBRATION KIT (K882220)King Diagnostics, Inc.1988-08-02
MEDIBLEND (TM) CLINICAL BLOOD GAS MIXTURES (K882209)Linde Div. Union Carbide Corp.1988-08-02
MODIFICATION OF BEHRING RAPIMAT II/T (K882095)Behring Diagnostics, Inc.1988-08-02
D-CHEM (K882307)Photec Diagnostics, Inc.1988-08-02
DIAZO, COLORIMETRIC BILIRUBIN (K882459)Tech-Neal Scientific, Inc.1988-08-02
QLT ABSOLUTE URINE-HCG PREGNANCY TEST (K881806)Quadra Logic Technologies, Inc.1988-08-02
GEM-STAT W/COMP. GEM-STATPAK/GEM-CHECK & CRIT CHK. (K882450)Diamond Sensor Systems1988-07-28
QTEST(TM) PREGNANCY (K882086)Quidel Corp.1988-07-28
AMERLITE LH-30 ASSAY, LAN.0082/2082 240/144 TEST (K880933)Amersham Corp.1988-07-28
CLEARBLUE EASY (K882416)Unipath , Ltd.1988-07-28
DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023 (K882259)Diagnostic Chemicals, Ltd. (Usa)1988-07-21
AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST (K881142)Amersham Corp.1988-07-21
REAGENTS FOR TSH ASSAY (K881381)Sclavo, Inc.1988-07-21
LYPHOCHEK UNASSAYED CHEMISTRY CONTROL (BOVINE)I/II (K882542)Bio-Rad1988-07-21
ACCUFIBRIN(TM) BLOOD COLLECTION SYSTEM AF100 (K882501)Terumo Medical Corp.1988-07-18
TRACER(TM) II BLOOD GLUCOSE SYSTEM (K881908)Boehringer Mannheim Corp.1988-07-12
LIQUI-SERA SERUM ALCOHOL CONTROLS (K881430)Biodiagnostic Intl1988-07-08
BLOOD PH CAPILLARY TUBES, HEPARIN (K881188)Helps Products, Inc.1988-07-08
IMMUNOCARD(TM) HCG II TEST KIT (K881709)Disease Detection International, Inc.1988-07-08
MODIFIED DADE COMPRE. ELECTROPHORESIS CONTROL (K881503)Baxter Healthcare Corp1988-07-08
QUANTAI BG(TM) REAGENT STRIP (K880703)Quantai Biotronics, Inc.1988-07-08
BIOTROL ALKALINE PHOSPHATASE (K881742)Biotrol, USA, Inc.1988-07-08
UNSATURATED IRON BINDING CAPACITY (K881761)Data Medical Associates, Inc.1988-07-08
APOLIPOPROTEIN FOR THE TECHNICON DPA-1(TM) SYSTEM (K882620)Technicon Instruments Corp.1988-07-08
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PROT) (K881639)Eastman Kodak Company1988-07-08
REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170 (K881852)Helena Laboratories1988-07-08
CHLORIDE/TOTAL CO2 SERUM RANGE LINEARITY STANDARDS (K881437)Hichem Diagnostics1988-07-06
UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN (K881438)Hichem Diagnostics1988-07-06
ION SELECTIVE ELECTRODE SUBSYSTEM OF PARA. ANALYT. (K882104)Paramax Systems Div. Baxter Healthcare1988-07-05
SPECIFIC CHEMISTRY ANALYZER (K882081)The Rupp & Bowman Co.1988-07-01
TERUMO SENSIBEAD(TM) EIA ESTRADIOL KIT (K882343)Terumo Medical Corp.1988-07-01
CLP LIPOPROTEIN ELECTROPHORESIS CONTROL (K881113)Creative Laboratory Products, Inc.1988-07-01
DSL SOMATOMEDIN-C (DSL #5600) (K875229)Diagnostic Systems Laboratories, Inc.1988-07-01
NOVA STAT PROFILE 6 ANALYZER + QUALITY CONTROL MAT (K880750)Nova Biomedical Corp.1988-07-01
BIOTROL TOTAL PROTEIN H.P. (K882189)Biotrol, USA, Inc.1988-07-01
ASTROSCAN 2100 MICROTITER PLATE READER (K881458)Astroscan , Ltd.1988-06-29
JAYCO HYDROGEN MONITOR (K882499)Enteron, Inc.1988-06-28
DELFIA ESTRADIOL KIT (K882173)Pharmacia, Inc.1988-06-24
TOTAL PROTEIN/ALBUMIN STANDARD (K882116)Verichem Laboratories, Inc.1988-06-24
HELENA REP GEL PROCESSOR (K882163)Helena Laboratories1988-06-20
BIOTROL CREATININE H.P. REAGENT (K881856)Biotrol, USA, Inc.1988-06-16
BICARBONATE (CO2) REAGENT-2 VIAL (K881938)Trace Scientific , Ltd.1988-06-15
EASY WASHER II MICROPLATE WASHER (K881797)Slt Labinstruments, Inc.1988-06-15
MODIFIED SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B (K881898)Atlantic Antibodies1988-06-14
COBAS EIA(TM) PHOTOMETER (K881877)Roche Diagnostic Systems, Inc.1988-06-10
HDL CHOLESTEROL KIT (K881244)Trace Scientific , Ltd.1988-06-10
EMIT CONVENIENCE PACK: T-UPTAKE ASSAY (K881855)Syva Co.1988-06-10
SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD (K864159)Chem-Elec, Inc.1988-06-10
DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET (K881773)Casco Standards1988-06-10
IQ HDL CHOLESTEROL (K881891)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-06-10
RAICHEM(TM) CALCIUM REAGENT (SINGLE STABLE LIQUID) (K880576)Reagents Applications, Inc.1988-06-10
PROLACTIN MAB SOLID PHASE COMPONENT SYSTEM (K881774)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-06-08
IMPRES-MB (K881801)Intl. Immunoassay Laboratories, Inc.1988-06-08
AMERLITE HCG-60 ASSAY, LAN.0083/2083 240KIT/144KIT (K881355)Amersham Corp.1988-06-08
TECHNICON CHEM 1(R) SYSTEM, DIRECT BILIRUBIN (K881798)Technicon Instruments Corp.1988-06-07
TERUMO SENSIBEAD EIA PROGESTERONE KIT (K881693)Terumo Medical Corp.1988-06-07
ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD) (K881173)Tech-Co, Inc.1988-06-07
BUN (KINETIC) (K881677)Boehringer Mannheim Corp.1988-06-07
DYNATECH SPD 2000, NUMBER 002-910-0000 (K881195)Dynatech Laboratories, Inc.1988-06-07
BILIRUBIN (DIRECT) (K881172)Tech-Co, Inc.1988-06-07
AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200 (K880654)American Research Products Co.1988-06-07
VITALOGRAPH-EC60 HYDROGEN MONITOR (K874892)Vitalograph , Ltd.1988-06-02
SODIUM/POTASSIUM SERUM RANGE LINEARITY STANDARDS (K881436)Hichem Diagnostics1988-06-02
SYNCHRON CX(TM)4 CLINICAL ANALYZER (K881498)Beckman Instruments, Inc.1988-06-01
SYNCHRON CX(TM)5 CLINICAL ANALYZER (K881495)Beckman Instruments, Inc.1988-06-01
VISION(R) LDH (LACTATE DEHYDROGENASE) (K881474)Abbott Laboratories1988-06-01
IMACK-MB, CATALOGS 602-1, 602-1/125, 602-1/225 (K881351)Intl. Immunoassay Laboratories, Inc.1988-06-01
RIA-QUICK (K881194)Quantitative Technologies, Inc.1988-06-01
REP LIPO KIT CAT. NO 3180 (K881809)Helena Laboratories1988-06-01
INCOS 50 MASS SPECTROMETER (K880418)Finnigan Corp.1988-05-31
URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C (K880584)Mach Diag. C/O Wichita State University1988-05-31
UVMAX KINETIC MICROPLATE READER (K881803)Molecular Devices Corp.1988-05-31
GAMMA GLUTAMYL TRANSFERASE REAGENT SET (K881239)Tech-Neal Scientific, Inc.1988-05-31
ABBOTT BREATH ACETONE ANALYZER (K875029)Abbott Laboratories1988-05-27
PREGNOSPIA II (K881435)Organon Teknika Corp.1988-05-27
SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL (K881655)Biomedical Research & Development Laboratories, Inc.1988-05-27
IMMPULSE T, ASSAY REAGENTS (K881214)Sclavo, Inc.1988-05-27
IQ POTASSIUM (K881440)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-05-27
GAMMA-GLUTAMYL TRANSFERASE (K881626)Tech-Co, Inc.1988-05-27
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