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Clinical Chemistry

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

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RecordFirmDate
PROGROUP (TM) AUTOMATED LIQUID HANDLING SYSTEM (K861580)Cetus Corp.1986-06-27
TWIN BUN/GLUCOSE (K861775)Boehringer Mannheim Corp.1986-06-27
ESTRADIOL MAIA RIA KIT MAGNETIC SEPARATION PHASE (K861361)Serono Diagnostics, Inc.1986-06-27
WORTHINGTON HDL PRECIPITATING REAGENT SET (K861926)Cooper Biomedical, Inc.1986-06-27
TRIGLYCERIDES GPO-TRINDER (K861635)Catachem, Inc.1986-06-27
CRESOLPHTHALEIN COMPLEXONE, CALCIUM (K860664)Amresco, Inc.1986-06-27
DIRECT BILIRUBIN PROCEDURE (K861671)Data Medical Associates, Inc.1986-06-25
ALT (SGPT) REAGENT SET (UV RATE) (K862209)Sterling Diagnostics, Inc.1986-06-25
ALT-30, 60 AND 100 (K861366)Dimension Diagnostics1986-06-25
GENTAMICIN (FPIA) CALIBRATOR KIT (K861769)Windsor Laboratories, Inc.1986-06-25
TOBRAMYCIN (FPIA) CALIBRATOR KIT (K861891)Windsor Laboratories, Inc.1986-06-25
PHENYTOIN (FPIA) CALIBRATOR KIT (K861770)Windsor Laboratories, Inc.1986-06-25
DOUBLE ANTIBODY CALCITONIN RIA KIT (K861274)Diagnostic Products Corp.1986-06-25
THEOPHYLLINE (FPIA) CALIBRATOR KIT (K861768)Windsor Laboratories, Inc.1986-06-25
DELFIA (TM) HFSH KIT (K862043)Lkb Instruments, Inc.1986-06-24
TERUMO SENSIBEAD EIA TSH KIT (K861573)Terumo Medical Corp.1986-06-19
QUIDEL BETA STICK PREGNANCY TEST (MODIFICATION) (K862207)Quidel Corp.1986-06-17
DELFIA (TM) HUMAN PROLACTIN (K861542)Lkb Instruments, Inc.1986-06-17
VISION TOTAL PROTEIN (K861798)Abbott Laboratories1986-06-17
VISION ALBUMIN (K862138)Abbott Laboratories1986-06-17
MULTI-4 CO-OXIMETER CONTROL (K861901)Allied Instrumentation Laboratory1986-06-17
DIRECT (K852960)University of Wisconsin1986-06-16
HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET (K861855)Sterling Diagnostics, Inc.1986-06-16
PTK PLUS. HOME PREGNANCY TEST (K861946)Healthcheck Corp.1986-06-16
SIMULTRAC NEONATAL T4(57CO)/TSH(125I) RADIOIMMUNO. (K861920)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-06-16
DOCUMENT ENZYME LINEARITY TEST SETS (K861506)Casco Standards1986-06-13
TOTAL PROTEIN PROCEDURE (K861663)Data Medical Associates, Inc.1986-06-13
BIOTEL (TM)/ DIABETES (K855239)American Diagnostic Corp.1986-06-13
URIC ACID PROCEDURE (K861660)Data Medical Associates, Inc.1986-06-13
CHOLESTEROL PROCEDURE (K861659)Data Medical Associates, Inc.1986-06-13
AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT SET (K861967)American Research Products Co.1986-06-13
SYVA SOLID PHASE COLUMNS SYSTEM II (K861392)Syva Co.1986-06-13
AMRESCO FLOW PAC INORGANIC PHOSPHRUS REAGENT SET (K861968)American Research Products Co.1986-06-13
LDP REAGENT CARTRIDGE (NO. 88216) (K862027)Hi Chem, Inc.1986-06-13
TIPSEP-TBG ASSAY (K861735)Nuclear Diagnostics, Inc.1986-06-13
LEE-BEAD PROLACTIN (EIA) (K861945)Leeco Diagnostics, Inc.1986-06-13
ALBUMIN PROCEDURE (K861654)Data Medical Associates, Inc.1986-06-13
DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM (K861700)E.I. Dupont DE Nemours & Co., Inc.1986-06-11
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CREA) (K861819)Eastman Kodak Company1986-06-11
VENTREX APO B (K861919)Ventrex Laboratories, Inc.1986-06-06
CREATINE PHROSPHOKINASE (CK) PROCEDURE (K861665)Data Medical Associates, Inc.1986-06-05
IRON PROCEDURE (K861652)Data Medical Associates, Inc.1986-05-29
CALCIUM PROCEDURE (K861657)Data Medical Associates, Inc.1986-05-29
RAICHEM AMYLASE REAGENT (K861269)Reagents Applications, Inc.1986-05-29
LACTATE DEHYDROGENASE (LD) PROCEDURE (K861662)Data Medical Associates, Inc.1986-05-29
ACID PHOSPHATASE PROCEDURE (K861675)Data Medical Associates, Inc.1986-05-29
CK REAGENT CARTRIDGE (PRODUCT NO. 88213) (K861879)Hi Chem, Inc.1986-05-29
TOTAL BILIRUBIN PROCEDURE (K861651)Data Medical Associates, Inc.1986-05-29
TRYPSIN RIA KIT (K861097)Microanalytic Research, Inc.1986-05-29
AST/GOT PROCEDURE (K861656)Data Medical Associates, Inc.1986-05-29
ALT/GPT PROCEDURE (K861658)Data Medical Associates, Inc.1986-05-29
STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III (K860906)American Dade1986-05-29
GAMMA GLUTAMYL TRANSFERASE PROCEDURE (K861672)Data Medical Associates, Inc.1986-05-29
AMYLASE REAGENT CATALOGUE NOS. 85108 AND 85109 (K861718)Reagents Applications, Inc.1986-05-29
ALKALINE PHOSPHATASE PROCEDURE (K861667)Data Medical Associates, Inc.1986-05-29
CK/LD BUFFER (CAT. NO. 5808) (K861750)Helena Laboratories1986-05-29
KINETIC ALKALINE PHOSPHATASE REAGENT KIT (K861638)Bio-Analytics Laboratories, Inc.1986-05-29
MAGNESIUM PROCEDURE (K861668)Data Medical Associates, Inc.1986-05-27
SODIUM, POTASSIUM AND CHLORIDE PROCEDURE (K861669)Data Medical Associates, Inc.1986-05-27
IRON PROCEDURE (K861603)Data Medical Associates, Inc.1986-05-23
QUANTIMETRIX HUMAN BILIRUBIN CONTROL I & II LIQUID (K860942)Quantimetrix Corp.1986-05-23
MODUMATIC (R) DILUTER (K861640)Tri-Continent Scientific, Inc.1986-05-23
TOTAL IRON BINDING CAPACITY PROCEDURE (K861602)Data Medical Associates, Inc.1986-05-23
DIRECT READOUT MODULE ACCESSORY (K861412)E.I. Dupont DE Nemours & Co., Inc.1986-05-23
MMS T3 UPTAKE (K861262)Micromedic Systems1986-05-23
ALBUMIN (BCG) REAGENT (K861467)Sigma Diagnostics, Inc.1986-05-23
EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95 (K861512)Em Diagnostic Systems, Inc.1986-05-23
GLUCOSE HK PROCEDURE (K861653)Data Medical Associates, Inc.1986-05-23
LIQUID CHROMATOGRAPHY COLUMNS (K861633)Supelco, Inc.1986-05-23
CONTROL SERA LEVEL VALUES (MG/DL) (K861567)E.I. Dupont DE Nemours & Co., Inc.1986-05-23
SERUM POTASSIUM REAGENT SET (K861713)Sterling Diagnostics, Inc.1986-05-23
THERACHEM-PLUS, TRI-LEVEL TDC (TM) (K861185)Fisher Scientific Co., LLC1986-05-23
EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95 (K860935)Em Diagnostic Systems, Inc.1986-05-23
BIOTRACK MONITOR (BIOTRACK REAGENT CARTRIDGES) (K860720)Biotrack, Inc.1986-05-23
THE PARTNER SPECTROPHOTOMETER (K861617)Pharmacia, Inc.1986-05-19
BIOTEL (TM)/UTI (K855238)American Diagnostic Corp.1986-05-09
VISION SGOT (AST) - ADDIT. OF WHOLE BLOOD CLAIM (K860465)Abbott Laboratories1986-05-05
MODEL K110SX CENTRIFUGE (K861146)Jouan S.A.1986-05-05
THE JR. PARTNER SPECTROPHOTOMETER (K861223)Pharmacia, Inc.1986-05-05
MINI-CHEM ANALYZER (K860987)Ocean Scientific, Inc.1986-05-05
DIRECTACLONE CG SLIDE PREGNANCY TEST (K860945)Pacific Biotech, Inc.1986-05-02
POSID SAMPLER (K860508)Organon Teknika Corp.1986-05-02
VMA BY HPLC TEST (VANILMANDELIC ACID) (K861010)Bio-Rad1986-05-01
ISOTRAK AMYLASE ISOENZYME CONTROL SET (K861329)Behring Diagnostics, Inc.1986-04-30
TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT (K860984)Hybritech, Inc.1986-04-29
AP REAGENT CARTRIDGE (K861284)Hi Chem, Inc.1986-04-28
AST REAGENT CARTRIDGE (K861283)Hi Chem, Inc.1986-04-28
IMMPULSE FREE ESTRIOL ASSAY REAGENTS (K860900)Sclavo, Inc.1986-04-28
HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE (K861419)Hi Chem, Inc.1986-04-28
ALT REAGENT CARTRIDGE (PRODUCT NO. 88210) (K861231)Hi Chem, Inc.1986-04-28
QUANTIMETRIX SERUM LIPID CONTROL I & II LIQUID (K861448)Quantimetrix Medical Industries1986-04-28
TSHK-NN RIA KIT (K860824)Cis-Us, Inc.1986-04-28
BILIRUBIN*SR (TOTAL) LIQUID STABLE REAGENT SET (K861413)Medical Analysis Systems, Inc.1986-04-24
GLUCOSE (HEXOKINASE) REAGENT SET (K861311)Sterling Diagnostics, Inc.1986-04-24
ENZYMATIC BUN REAGENT (K860716)Trace Scientific , Ltd.1986-04-24
MMS T4 RIA KIT (K861320)Micromedic Systems1986-04-24
BETA QUIK STICK (K860965)Pacific Biotech, Inc.1986-04-24
EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK (K861061)Em Diagnostic Systems, Inc.1986-04-24
LACTATE DEHYDROGENASE (LD) FOR CONT. FLOW INSTRUM. (K860713)Catachem, Inc.1986-04-24
CLEARBLUE PREGNANCY TESTING KIT (K861168)Unipath , Ltd.1986-04-24
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