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Clinical Chemistry

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

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RecordFirmDate
A-QC CLINICAL CHEMISTRY CONTROL (K873611)Arden Medical Systems, Inc.1987-10-20
ALBUMIN SCREEN TEST (K870516)Sclavo, Inc.1987-10-20
URIC ACID PAP (K873363)Boehringer Mannheim Corp.1987-10-19
GEMSTAR II SYSTEM (K873617)Electro-Nucleonics Laboratories, Inc.1987-10-19
CIBA CORNING/SHIMADZU MODEL 570 CHEM. ANALYZER (K873749)Ciba Corning Diagnostics Corp.1987-10-19
APOLIPOPROTEIN B (K873864)Unipath , Ltd.1987-10-13
APOLIPOPROTEIN A1 (K873863)Unipath , Ltd.1987-10-13
MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. TEST KIT (K873355)Medix Biotech, Inc.1987-10-09
MULTI-ACCESS REAGENT DISPENSER (K873416)Electro-Nucleonics Laboratories, Inc.1987-10-09
MULTICHEM ALKALINE PHOSPHATASE (S0903) (K873761)Simmler, Inc.1987-10-07
MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT (K873668)Medix Biotech, Inc.1987-10-07
AFFINITY HCG IMMUNIT (POLYCLONAL) (K873524)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-10-06
BNP-AMYLASE TEST (K873133)Sclavo, Inc.1987-10-06
WAKO(TM) AUTOKIT UREA N (K873335)Wako Chemicals USA, Inc.1987-10-02
BINAX L.S. TSH IRMA TEST KIT (K873303)Binax, Inc.1987-10-02
WAKO(TM) AUTOKIT ALP (K873333)Wako Chemicals USA, Inc.1987-10-02
TITAN GEL HDL CHOLESTEROL KIT (K873547)Helena Laboratories1987-10-02
ANSWER OVULATION TEST KIT (K871241)Armkel, LLC1987-10-02
WAKO(TM) AUTOKIT CALCIUM (K873334)Wako Chemicals USA, Inc.1987-10-02
CREATININE REAGENT (K873365)Sigma Diagnostics, Inc.1987-10-02
MULTICHEM CALCIUM S0910 (K873697)Simmler, Inc.1987-10-02
CONJUGATED BILIRUBIN (CBIL) ITEM NO. 67684/95 (K873551)Em Diagnostic Systems, Inc.1987-10-02
LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA (K873186)Serono Diagnostics, Inc.1987-09-29
G-GT STANDARD CALIBRATOR (K871759)Wako Chemicals USA, Inc.1987-09-29
SPECTROPHOTOMETER (MICROASSAY PLATE READERS) (K873678)Slt Labinstruments, Inc.1987-09-29
ALKALINE PHOSPHATASE (ALK P) TESTPACK #67690/95 (K873681)Em Diagnostic Systems, Inc.1987-09-29
MICRO-CHEM ANALYZER (K873638)Ocean Scientific, Inc.1987-09-29
STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY (K873171)American Dade1987-09-29
DOUBLE ANTIBODY ULTRA-PTH #KPTD1 AND KPTD2 (K871970)Diagnostic Products Corp.1987-09-25
PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA (K873400)Serono Diagnostics, Inc.1987-09-25
MEDIX BIOTECH APOLIPOPROTEIN A-I TEST KIT (K872794)Medix Biotech, Inc.1987-09-23
AUTO-EIA (K873583)Labsystems, Inc.1987-09-22
FINNIGAN MAT INCOS 50 (K873603)Finnigan Corp.1987-09-22
WAKO(TM) PRETEST 8A (K873553)Wako Chemicals USA, Inc.1987-09-22
TRI-LEVEL LIGAND CONTROL (K873450)Ciba Corning Diagnostics Corp.1987-09-21
CALCIUM CALIBRATOR (K872051)Wako Chemicals USA, Inc.1987-09-18
PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS (K872862)Serono Diagnostics, Inc.1987-09-18
COULTER DART CK-MB ISOENZYME REAGENT SYSTEM (K872041)Coulter Electronics, Inc.1987-09-16
SPECTROPHOTOMETERS MODELS:ABC+,ABC,S 500, S 1000 (K872749)Secomam Co.1987-09-16
UNIFAST CK-MB (K873134)Sclavo, Inc.1987-09-16
GLUCOCHEK S.C. WITH AUDIO OPTION (K871586)Larken Industries, Inc.1987-09-16
REFLO-CHEX, A CHOLESTEROL REFERENCE CONTROL (K873105)Streck Laboratories, Inc.1987-09-16
LACTATE DEHYDROGENASE ISOENZYME 1 (K872891)Data Medical Associates, Inc.1987-09-16
HCG SEROZYME IMMUNOENZYM ASSAY KIT/MAG SOLID PHASE (K873033)Serono Diagnostics, Inc.1987-09-14
VIRON(TM) (K872646)bioMerieux, Inc.1987-09-14
MICRO-READER II (K873138)Hyperion, Inc.1987-09-14
DIAGNOSTIC KIT FREE T3 AND FREE T4 (K870268)Sclavo, Inc.1987-09-14
STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY (K873052)American Dade1987-09-14
EASY-TEST CONJUGATED BILIRUBIN (CBIL) #16690 (K873424)Em Diagnostic Systems, Inc.1987-09-14
BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052 (K872073)American Monitor Corp.1987-09-11
GEMENI URIC ACID U.V. (K873358)Electro-Nucleonics Laboratories, Inc.1987-09-11
'MICROLYTE 4/5' (K873345)Kone Instruments, Inc.1987-09-11
GAMMA GLUTAMYLTRANSFERASE (K873378)Catachem, Inc.1987-09-08
RAPID ELECTROPHORESIS SYSTEM (REP) (K873352)Helena Laboratories1987-09-08
MODEL 690 SPECTROPHOTOMETER (K873408)Abbott Diagnostics1987-09-08
MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER (K872302)Ciba Corning Diagnostics Corp.1987-09-08
BIOTROL TRIGLYCERIDES ENZYMATIQUE COLOR (K873160)Biotrol, USA, Inc.1987-09-08
BIOTROL ALPHA AMYLASE (K872831)Biotrol, USA, Inc.1987-09-04
UNIFAST GAMMA-GT (K873135)Sclavo, Inc.1987-09-04
ALLEGRO(TM) HUMAN CHORIONIC GONADOTROPIN IM SYSTEM (K872390)Nichols Institute Diagnostics1987-09-02
QUICK QUALITATIVE CALCIUM TEST (QUICK-CAL) (K871903)Creative Scientific Technology, Inc.1987-09-02
CYBERFLUOR 615 IMMUNOANALYZER (K872803)Cyberfluor, Inc.1987-09-02
ABBOTT SPECTRUM(R) LIQUID CREATININE REAGENT (K873310)Abbott Laboratories1987-09-02
BIOTROL MAGNESIUM CALMAGITE (K873180)Biotrol, USA, Inc.1987-09-02
MULTI ANALYTE MIXTURES, CALIBRATORS (K873116)Biotrol, USA, Inc.1987-09-02
BIOTROL REFERENCE (K873118)Biotrol, USA, Inc.1987-09-02
PARAMAX URINE/CSF CALIBRATOR (K872789)American Dade1987-09-02
BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT (K873117)Biotrol, USA, Inc.1987-08-31
CURAD MEDICATED PLASTIC STRIPS (K872310)The Kendal Co.1987-08-28
TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL (K873049)Boehringer Mannheim Corp.1987-08-28
ANTEK 703C CHEMILUMINESCENT NITROGEN ANALYZER (K864849)Antek Instruments, Inc.1987-08-28
BIOTROL-33 PLUS ASSAYED CHEMISTRY CONTROL SERUM (K872785)Biotrol, USA, Inc.1987-08-26
BILE ACIDS REAGENT (K872296)Sigma Diagnostics, Inc.1987-08-26
BIOTROL-33 PLUS PATHOLOGIQUE ASSAYED CHEM. CONTROL (K872777)Biotrol, USA, Inc.1987-08-26
ADVANCE* PREGNANCY TEST ACP 2 PREGNANCY TEST (K871601)Advanced Care Products1987-08-26
TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAY (K872131)Hybritech, Inc.1987-08-25
CIBA CORNING 288 PH/BLOOD GAS SYSTEM (K872888)Ciba Corning Diagnostics Corp.1987-08-25
ABBOTT A-GENT IRON REAGENT KIT (K873120)Abbott Laboratories1987-08-25
PROTOFLUOR Z (K871499)Helena Laboratories1987-08-25
BIOTROL CHOLESTEROL ENZYMATIQUE COLOR (K872930)Biotrol, USA, Inc.1987-08-21
ISO-DATA 500 SERIES GAMMA COUNTER (K872430)Iso-Data, Inc.1987-08-21
CEDIA(TM) T UPTAKE (K872447)Microgenics Corp.1987-08-21
EASY-TEST TOTAL BILIRUBIN (TBIL) ITEM NO. 16604 (K872513)Em Diagnostic Systems, Inc.1987-08-21
CALCIUM REAGENT - CRESOLPHTHALEIN COMPLEXON METHOD (K870362)Trace Scientific , Ltd.1987-08-21
EMDS TOTAL BILIRUBIN (TBIL) TESTPACKS, #67675/95 (K872512)Em Diagnostic Systems, Inc.1987-08-21
GEN-PROBE (R) LUMINOMETER - LEADER (TM) (K872219)Gen-Probe, Inc.1987-08-21
BILE ACIDS CALIBRATOR (K872451)Sigma Diagnostics, Inc.1987-08-21
CHLORIDE REAGENT - THIOCYANATE METHOD (K870367)Trace Scientific , Ltd.1987-08-21
ISO-DATA 100 SERIES GAMMA COUNTER (K872429)Iso-Data, Inc.1987-08-21
VISION(R) TOTAL BILIRUBIN (K872487)Abbott Laboratories1987-08-21
MODIFIED ENZYMATIC BUN REAGENT (K872484)Trace Scientific , Ltd.1987-08-19
ALBUMIN REAGENT - BROMCRESOL GREEN METHOD (K870372)Trace Scientific , Ltd.1987-08-19
CALCIUM REAGENT-METHYL THYMOL BLUE METHOD (K870369)Trace Scientific , Ltd.1987-08-19
MODIFIED ALT (GPT) REAGENT (K872483)Trace Scientific , Ltd.1987-08-19
PHOSPHORUS REAGENT-DIRECT UV METHOD W/O REDUCTION (K870368)Trace Scientific , Ltd.1987-08-19
CREATININE REAGENT - PICRIC ACID METHOD (K870366)Trace Scientific , Ltd.1987-08-19
TOTAL PROTEIN REAGENT - BIURET METHOD (K870371)Trace Scientific , Ltd.1987-08-19
DIRECT BILIRUBIN REAGENT - ACID DIAZO METHOD (K870365)Trace Scientific , Ltd.1987-08-19
MAGNESIUM REAGENT - CALMAGITE METHOD (K870370)Trace Scientific , Ltd.1987-08-19
TOTAL BILIRUBIN REAGENT - DMSO METHOD (K870364)Trace Scientific , Ltd.1987-08-19
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