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Clinical Chemistry

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

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RecordFirmDate
BEHRING ELISA PROCESSOR M (K841043)Behring Diagnostics, Inc.1984-07-06
GASTRIN 34 HORMONE BY RADIOUMMUNOASSAY (K842079)Immuno Nuclear Corp.1984-06-26
WAKO B.G. PRETEST STRIPS (K842207)Healthdyne, Inc.1984-06-26
SIGMA PROCEDURE 47-UV (K842013)Sigma Chemical Co.1984-06-25
THYROXINE-BINDING GLOBULIN RADIOUMMU (K842010)Nichols Institute Diagnostics1984-06-25
TESTOSTERONE DIRECT RADIOIMMUNOASSAY (K841948)Sorin Biomedica, Fiat, USA, Inc.1984-06-25
VITAMIN B12 57CO/FOLATE 125I - (K840462)Corning Medical & Scientific1984-06-25
T3 UPTAKE (K841927)Syncor Intl. Corp.1984-06-25
GASTRIN RIA (K841963)Syncor Intl. Corp.1984-06-25
DUPONT ACA MAGNESIUM CALIBRATOR (K841955)E.I. Dupont DE Nemours & Co., Inc.1984-06-25
LYRIS MODULAR INFO SYSTEM (K831830)Biovation, Inc.1984-06-25
ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT (K841947)Sorin Biomedica, Fiat, USA, Inc.1984-06-25
FLAME PHOTOMETERS (K834226)Dr. Bruno Lange GmbH1984-06-22
PARAMAX IRON BLANK REAGENT (K841887)American Dade1984-06-22
DIAGNON FOLATE 125I RIA KIT (K841302)Diagnon Corp.1984-06-22
REFLOCHECK-S (K840962)Boehringer Mannheim Corp.1984-06-22
TIBC PRETREATMENT KIT (K842019)E.I. Dupont DE Nemours & Co., Inc.1984-06-22
BHCG RIA (K841854)Syncor Intl. Corp.1984-06-22
ION 4 SODIUM/POTASSIUM/CHLORIDE/TOTAL (K842025)Hi Chem, Inc.1984-06-22
DIATRON EASYTEST BLOOD GLUCOSE MONI (K840484)Medivix, Inc.1984-06-22
ELECTROLYTE ANALYZER SERA-210 (K841424)Horiba Instruments, Inc.1984-06-22
ELVI 165 PROTEO SEROSKOP (K842056)Logos Scientific, Inc.1984-06-22
CA-1511, IN VITRO RADIOIMMUNOASSAY (K841821)Travenol Laboratories, S.A.1984-06-22
CHANGES IN THE CHEMICAL COMP. OF 5 (K841464)Nova Biomedical Corp.1984-06-22
ABBOTT PROJECT I (K841916)Abbott Laboratories1984-06-22
CHLORIDE TEST KIT (K842011)Mallinckrodt Critical Care1984-06-22
PARAMAX IRON REAGENT (K841886)American Dade1984-06-22
NOVA STAT CONTROL LEVELS 1/2/3 (K841452)Nova Biomedical Corp.1984-06-22
PREG-BETA ONE HOUR TUBE TEST (K841853)Intl. Diagnostic, Inc.1984-06-22
BLOOD GAS CONTROL, LEVEL I(ACIDOSIS (K841783)Bionostics, Inc.1984-06-14
RIANEN CYCLIC-AMP RADIOIMMUNOASSAY (K841478)New England Nuclear1984-06-14
VARIAN 2000 LIQUID CHROMATOGRAPHY ANALY (K841890)Varian Assoc., Inc.1984-06-14
SIGMS PROCED. 228 UV LACTATE DEHYDRO (K841917)Sigma Diagnostics, Inc.1984-06-14
UREA NITROGEN REAGENT SET (K840064)Sterling Biochemical, Inc.1984-06-14
SIGMA PROCED. 245 ALKALINE PHOSPHATASE (K841918)Sigma Diagnostics, Inc.1984-06-14
AUTOMATED EIA MICROPLATE READER EL310 (K842085)Bio-Tek Instruments, Inc.1984-06-11
TDX REA LDH (K841703)Abbott Laboratories1984-06-08
ENZYMATIC CO2 DIAGNOSTIC CHEMICAL (K841664)Diagnostic Chemicals, Ltd. (Usa)1984-06-08
RAICHEM BILIRUBIN REAGENT TOTAL/DIRECT (K841892)Reagents Applications, Inc.1984-06-07
CM-TRISACRYL M DEAE-TRISACRYL M (K842028)Lkb Instruments, Inc.1984-06-07
DEMAND C02 (K841726)Cooper Biomedical, Inc.1984-06-07
OREIA II B-HCG PREGNANCY TEST KIT (K841525)Organon, Inc.1984-06-05
KYOTEST 2V, URINE TEST REAGENT STRIP (K841714)Kyoto Diagnostics, Inc.1984-05-31
ELVI 70 SAFETY CHAMBER (K841804)Logos Scientific, Inc.1984-05-31
KYOTEST UK URINE TEST REAGENT STRIP (K841715)Kyoto Diagnostics, Inc.1984-05-31
KYOTEST UG URINE TEST REAGENT STRIP (K841713)Kyoto Diagnostics, Inc.1984-05-31
TDX REA URIC ACID (K841702)Abbott Laboratories1984-05-31
HEALTHCHECK HOME PREGNANCY TEST KIT (K841595)Timex Medical Products Corp.1984-05-31
ELVI 444 BILITRON (K840757)Logos Scientific, Inc.1984-05-30
PREG BETA BLUS SLIDE (K840833)Intl. Diagnostic, Inc.1984-05-30
COMPONENTS FOR PARTIAL PRESSURE ELEE (K841609)Shaban Mfg. Co.1984-05-25
COMPONENTS FOR POTASSIUM, SODIUM CHLO (K841610)Shaban Mfg. Co.1984-05-25
AMNIO STAT-FLM AGGLUTINATION TEST (K834616)Hana Biologics, Inc.1984-05-25
BLOOD SPOT NEONATAL TSH RADIOIMMUNO (K841606)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-05-22
SIGMA PROCEDURE 16-UV (K841555)Sigma Chemical Co.1984-05-22
TERUMO SENSIBEAD THYROXINE EIA KIT (K841601)Terumo Medical Corp.1984-05-22
ORTHO MICROWELL READER (K841557)Ortho Diagnostic Systems, Inc.1984-05-22
TECHNICON RA-1000 SYS T4-THYROXINE (K841576)Technicon Instruments Corp.1984-05-22
AMRESCO E4A REAGENT SET (K840868)American Research Products Co.1984-05-22
LINEAR CLOUD TONOMETER (K841089)Linear Tonometers, Inc.1984-05-22
KODAK EKTACHEM DT 60 ANALYZER (K841503)Eastman Kodak Company1984-05-22
ACCURATE BETA 30 PREGNANCY TEST KIT (K841602)Organon, Inc.1984-05-22
VENTREXYME EIA CONTROLS IMMUNOASSAY (K841456)Vxr, Inc.1984-05-21
CAPILLARY GAS CHROMATOGRAPHIC COLUMNS (K841712)Supelco, Inc.1984-05-21
SODIUM ELECTRODE RINSE SOLUTION 2 (K841418)Reagent Laboratory, Inc.1984-05-16
CORNING LACTATE DEHYDROPHORETIC ASSAY (K841433)Corning Medical & Scientific1984-05-16
TOTAL PROTEIN REAGENT BIURET (K841466)Reagents Applications, Inc.1984-05-16
ULTRA CHEM ENZYMATIC TRIGLYCERIDE (K841471)Em Diagnostic Systems, Inc.1984-05-16
INSULIN RADIOIMMUNOASSAY KIT (K841573)Sorin Biomedica, Fiat, USA, Inc.1984-05-16
UNIPAK 100 ANALYZER, 65156 & CHEMISTR (K840883)Emd Chemicals, Inc.1984-05-16
DIRECT BILIRUBIN REAGENT (K841572)Hi Chem, Inc.1984-05-16
POTASSIUM CHLORIDE SOLUTION -2 MOLAR (K841417)Reagent Laboratory, Inc.1984-05-16
ORTHO ENZYME IMMUNOASSAY HOME PREG.TEST (K834270)Advanced Care Products1984-05-14
KYOTEST 5V (K840827)Kyoto Diagnostics, Inc.1984-05-14
KYOTEST 8V (K840828)Kyoto Diagnostics, Inc.1984-05-14
YD STRIP GPH U21 (K834387)Yd Pharmaceutical Corp.1984-05-14
YD STRIP GP U20 (K834386)Yd Pharmaceutical Corp.1984-05-14
PROLACTIN RIABEAD PROLACTIN RADIOIMM (K841118)Abbott Laboratories1984-05-11
SODIUM & POTASSIUM STANDARD SOLUT (K841419)Reagent Laboratory, Inc.1984-05-11
SODIUM & POTASSIUM STANDARD SOL 80 (K841420)Reagent Laboratory, Inc.1984-05-11
CREATININE - A.A.S. (K841377)Advanced Analytical Systems, Inc.1984-05-11
DIFFU-GEN APOLIPOPROTEIN A-I RADIAL - (K834218)Tago, Inc.1984-05-11
DAILY WASH SOLUTION 5 (K841421)Reagent Laboratory, Inc.1984-05-11
YD STRIP GLUCOSE U19 (K834385)Yd Pharmaceutical Corp.1984-05-11
VOLUME TEST DYE 6 (K841422)Reagent Laboratory, Inc.1984-05-11
ASTRA SYS INORGANIC PHOSPHORUS CHEM (K841181)Beckman Instruments, Inc.1984-05-09
VENTREZYME T4U IMMUNOASSAY T4U (K841024)Ventrex Laboratories, Inc.1984-05-09
MULTIPLE CHEM. MODULE FOR ANALYSIS (K841182)Beckman Instruments, Inc.1984-05-09
CK-B RIA KIT (K840549)Diagnostic Systems Laboratories, Inc.1984-05-07
ION SELECTIVE ELECTRODE (K841076)Cooper Biomedical, Inc.1984-05-07
HUMAN GROWTH HORMONE RIA KIT (K841094)Diagnostic Products Corp.1984-05-07
BIODEX ACT-O-KIT TSH-RIA- (K840088)Biodan Medical Systems, Ltd.1984-05-07
CENTRIFUGES (K840768)Heraeus-Christ GmbH1984-05-07
DETERMINATION OF MAGNESIUM IN SERUM OR (K841259)Sigma Chemical Co.1984-05-07
CORNING IMMO PHASE FREE T3 (K840222)Corning Medical & Scientific1984-05-07
VENTREZYME BETA-HCG IMMUNOASSAY HCG (K841081)Ventrex Laboratories, Inc.1984-05-07
ELVI 18 (K841288)Logos Scientific, Inc.1984-05-02
ND1200 RIA COUNTER (K841352)Nuclear Data, Inc.1984-05-02
TECHNICON RA-1000 SYS CO2 (K841080)Technicon Instruments Corp.1984-05-02
PROGESTERONE DIRECT RIA KIT-RADIOIMM (K841333)Biotecx Laboratories, Inc.1984-05-02
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