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Clinical Chemistry

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

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RecordFirmDate
NOVA NA/K/CL/LI MODULE (K922943)Nova Biomedical Corp.1992-10-13
MICROLITE MICROTITER PLATE LUMINOMETER ML3000 (K923456)Dynatech Laboratories, Inc.1992-10-13
MULTIQUAL UNASSAYED PRODUCTS (K923632)Ciba Corning Diagnostics Corp.1992-10-13
CREATINE KINASE (CK) TEST ITEM #65411 (K924704)Em Diagnostic Systems, Inc.1992-10-13
MULTIQUAL ASSAY PRODUCTS (K923633)Ciba Corning Diagnostics Corp.1992-10-13
ACCUDATA GLUCOSE TEST STATION (K924475)Boehringer Mannheim Corp.1992-10-13
VISTA THYROXINE UPTAKE ASSAY (K923676)Syva Co.1992-10-09
IMMUCHEM PRL-MW ELISA (K922715)Icn Biomedicals, Inc.1992-10-05
KING DIAGNOSTICS CHLORIDE REAGENT (K922921)King Diagnostics, Inc.1992-10-05
ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT (K922376)Icn Biomedicals, Inc.1992-10-05
OLYMPUS TOTAL BILIRUBIN REAGENT (K923609)Olympus Corp.1992-10-02
OLYMPUS CHLORIDE REAGENT (K923610)Olympus Corp.1992-10-02
OLYMPUS AMYLASE REAGENT (K923346)Olympus Corp.1992-10-02
VISUAL HCG PREGNANCY TEST (K923376)Tech-Co, Inc.1992-10-01
IL TEST GLUCOSE, PN 181633-80 (K922532)Instrumentation Laboratory CO1992-09-30
KING DIAGNOSTICS MAGNESIUM REAGENT (K923927)King Diagnostics, Inc.1992-09-30
ANALYZER: NOVA 10 CRT ANALYZER & QUALI CONT MATER (K923806)Nova Biomedical Corp.1992-09-29
ATAC 6000 CHEMISTRY ANALYZER (K924084)Bio-Chem Laboratory Systems, Inc.1992-09-29
OLYMPUS IRON REAGENT (K923565)Olympus Corp.1992-09-28
OLYMPUS ALKALINE PHOSPHATASE REAGENT (K923527)Olympus Corp.1992-09-28
MILES URINE AMYLASE METHOD (K923105)Heraeus Kulzer, Inc.1992-09-28
EMDS ALANINE AMINOTRANSFER TEST(ALT) TECH RA 1000 (K923257)Em Diagnostic Systems, Inc.1992-09-28
GAMMA GULTAMYL TRANSFERASE TEST (K922947)Em Diagnostic Systems, Inc.1992-09-28
KODAK AMERLITE TOTAL THYROID CONTROL SERA (K923740)Eastman Kodak Company1992-09-25
ENCORE TEST STRIPS (K923018)Heraeus Kulzer, Inc.1992-09-23
GLUCOSE 3 (K922035)Caro Med, Inc.1992-09-23
TITAN GEL ALKALINE PHOSPHATASE (HR) (K921578)Helena Laboratories1992-09-23
TECHNICON IMMUNO 1 SYSTEM TOTAL TRIIODOTHYRONINE (K923258)Heraeus Kulzer, Inc.1992-09-23
DU PONT ACA MASS CREATIVE KINASE MB (MCKMB) CALIBR (K922699)E.I. Dupont DE Nemours & Co., Inc.1992-09-23
MILES AUTO METH DETERMIN OF URIC ACID IN URINE (K924129)Heraeus Kulzer, Inc.1992-09-22
SYSTEMATE URICACID TEST, TECHNICON RA 1000 (K923765)Em Diagnostic Systems, Inc.1992-09-22
MICROBACT SOLID PLATE SYSTEMS (K923342)Radiometer America, Inc.1992-09-22
SYNERMED 600 NM URIC ACID REAGENT KIT (K923414)Synermed, Inc.1992-09-22
SYSTEMATE PHOSPHORUS TEST TECHNICON RA 1000 (K923764)Em Diagnostic Systems, Inc.1992-09-22
OLYMPUS LACTATE DEHYDROGENASE REAGENT (K923412)Olympus Corp.1992-09-18
OLYMPUS CREATININE REAGENT (K923526)Olympus Corp.1992-09-18
VISTA THYROXINE (T-4) ASSAY -- MODIFICATION (K922433)Syva Co.1992-09-18
IL TEST ALT, PN 35311 (K923623)Instrumentation Laboratory CO1992-09-17
STRATUS FOLATE FLUOROMETRIC ENZYME-LINKED ASSAY (K923286)Baxter Diagnostics, Inc.1992-09-17
ONE TOUCH IIB BLOOD GLUCOSE METER (K922888)Lifescan, Inc.1992-09-15
ANI BIOCARD HCG TEST (K923030)Ani OY1992-09-15
MILES URINE GLUCOSE METHOD (K923040)Heraeus Kulzer, Inc.1992-09-15
MILES URINE CALCIUM METHOD (K923034)Heraeus Kulzer, Inc.1992-09-15
IQ IMMUNOCHEMISTRY SISTEM; IQ TSH ASSAY (K923060)Becton Dickinson Advanced Diagnostics1992-09-15
TRACE ALBUMIN-MR REAGENT (K923322)Trace Scientific , Ltd.1992-09-11
WATERS(TM) LC MODULE I FOR CLINICAL USE (K922388)Millipore Corp.1992-09-11
SYSTEMATE CALCIUM TEST TECHNICON RA 1000 (K922953)Em Diagnostic Systems, Inc.1992-09-09
SYSTAMATE ASPARTATE AMINOTRANSFERASE TEST TECHNICO (K922857)Em Diagnostic Systems, Inc.1992-09-09
TOTAL BILIRUBIN CATALOG NO. 65407 (K923083)Em Diagnostic Systems, Inc.1992-09-09
SYSTEMATE CREATININE TEST (K923203)Em Diagnostic Systems, Inc.1992-09-09
DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH METHOD (K922701)E.I. Dupont DE Nemours & Co., Inc.1992-09-09
MILES URINE UREA NITROGEN METHOD (K923035)Heraeus Kulzer, Inc.1992-09-09
SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000 (K923267)Em Diagnostic Systems, Inc.1992-09-09
DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH CALIBRATOR (K922698)E.I. Dupont DE Nemours & Co., Inc.1992-09-09
URINE CHLORIDE (K923036)Heraeus Kulzer, Inc.1992-09-09
AMYLASE TEST (K923677)Em Diagnostic Systems, Inc.1992-09-09
KING DIAGNOSTICS CHOLESTEROL REAGENT (K923128)King Diagnostics, Inc.1992-09-09
SYSTEMATE DIRECT BILIRUBIN TEST TECHNICON RA 1000 (K922856)Em Diagnostic Systems, Inc.1992-09-09
HCG PREGNANCY ONE STEP TEST STRIP (K923123)Tcpi, Inc.1992-09-09
KING DIAGNOSTICS GAMMA GT REAGENT (K923091)King Diagnostics, Inc.1992-09-09
AMERLITE PROLACTIN-30 ASSAY (K922170)Eastman Kodak Company1992-09-02
COTUBE PTH IRMA (K921949)Bio-Rad1992-09-02
LABOTECH AUTOMATED MICROTITER ANALYZER (K922081)Innovative Medical Systems, Inc.1992-09-02
MONI-TROL-L AND MONI-TROL-XL (K920291)Medical Analysis Systems, Inc.1992-09-02
TOTAL T3 CHEMILUMINESCENCE ASSAY (K923015)Nichols Institute Diagnostics1992-09-02
SAF-T HOLDER MULTI SAMPLE LUER ADAPTER W/ BLOOD (K923090)Ryan Medical, Inc.1992-09-01
ABL50 BLOOD GAS SYSTEM (K922922)Radiometer America, Inc.1992-08-28
PARAMAX TOTAL IRON BINDING CAPACITY PRETREATMENT (K923569)Baxter Diagnostics, Inc.1992-08-26
MILES POTASSIUM METHOD (K923038)Heraeus Kulzer, Inc.1992-08-24
MILES URINE CREATININE METHOD (K923039)Heraeus Kulzer, Inc.1992-08-24
DU PONT ACA PLUS IMMUNOASSAY SYSTEM INSTRUMENT (K922680)E.I. Dupont DE Nemours & Co., Inc.1992-08-20
DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH. (K922700)E.I. Dupont DE Nemours & Co., Inc.1992-08-20
ARRAY(R) 360 (K922273)Beckman Instruments, Inc.1992-08-19
REP SPE PLUS (PONCEAU S) SYSTEM (K922053)Helena Laboratories1992-08-18
OLYMPUS MAGNESIUM REAGENT (K923411)Olympus Corp.1992-08-18
QUICK-CHECK II REAGENT STRIP (K921825)Diagnostic Solutions, Inc.1992-08-18
KING DIAGNOSTIC TRIGLYCERIDES REAGENT (K922964)King Diagnostics, Inc.1992-08-18
OLYMPUS DIRECT BILIRUBIN REAGENT (K923608)Olympus Corp.1992-08-18
UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311 (K922770)Leica, Inc.1992-08-18
OLYMPUS INORGANIC PHOSPHORUS REAGENT (K923564)Olympus Corp.1992-08-18
NOVA TOTAL PROTEIN MODULE (K923266)Nova Biomedical Corp.1992-08-12
VACU-PRO (K922445)Concord/Portex1992-08-12
DENLEY WELLPREP 2 SAMPLE PROCESSOR (K922327)Denley Instruments, Inc.1992-08-12
DU PONT ACA PLUS IMMUNOASSSAY SYSTEM HCG CALIBRATO (K922696)E.I. Dupont DE Nemours & Co., Inc.1992-08-12
LIPID CONTROLS (K922995)Creative Laboratory Products, Inc.1992-08-12
WELLPREP 2000 SAMPLE PROCESSOR (K922183)Denley Instruments, Inc.1992-08-11
AMERLITE FREE THYROID CONTROL SERA LAN.4002 (K923165)Eastman Kodak Company1992-08-10
DU PONT ACA PLUS IMMUNOASSAY SYSTEM HCG METHOD (K922697)E.I. Dupont DE Nemours & Co., Inc.1992-08-10
ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTS (K922823)Bio-Rad Laboratories, Inc.1992-08-05
CALCIUM (AZ III) REAGENT (K922835)King Diagnostics, Inc.1992-08-04
BIOTROL BICARBONATE STANDARDS (K921855)Biotrol, USA, Inc.1992-08-03
ENZIP URINARY MICROALBUMIN TEST (K922032)Diagnostic Specialties1992-07-30
HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO (K921745)Hybritech, Inc.1992-07-30
AFFIRM PROCESSOR (K923268)Microprobe Corp.1992-07-30
RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II (K922904)Reagents Applications, Inc.1992-07-30
ZITHROMAX (K922792)Difco Laboratories, Inc.1992-07-30
COBAS CORE IMMUNOCHEMISTRY SYSTEM (K921180)Roche Diagnostic Systems, Inc.1992-07-28
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (K921302)Vitek Systems, Inc.1992-07-28
OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT (K922885)Olympus Corp.1992-07-28
OLYMPUS ALANINE AMINOTRANSFERASE REAGENT (K922884)Olympus Corp.1992-07-28
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