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Clinical Chemistry

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

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RecordFirmDate
ABSORBANCE (ABS) TEST PAK (K854784)Diagnostic Systems1985-12-19
DSL ANDROSTENDIONE RIA (DSL #4200) (K854674)Diagnostic Systems Laboratories, Inc.1985-12-19
OVUTIME OVULATION PREDICTOR TEST (K853142)Advanced Care Products1985-12-17
DSL PROGESTERONE RIA (DSL #3400) (K854649)Diagnostic Systems Laboratories, Inc.1985-12-13
DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800) (K854650)Diagnostic Systems Laboratories, Inc.1985-12-13
RAICHEM CO2 REAGENT (K854544)Reagents Applications, Inc.1985-12-13
PARAAMAX CHLORIDE DETERMINATION BY ISE (K854651)American Dade1985-12-13
MGA 2000 GAS ANALYSER (K854076)Airspec , Ltd.1985-12-11
QUANTIMETRIX BIURET SERUM TOTAL PROTEIN ASSAY KIT (K853930)Quantimetrix Corp.1985-12-10
LIFE WATCH RESPIRATORY MONITOR (K853840)The Perkin-Elmer Corp.1985-12-09
TERUMO SENSIBEAD EIA COLORIMETER (K854210)Terumo Medical Corp.1985-12-05
ULTRAZYME PLUS & SYSTEMATE LDH (K854585)Em Diagnostic Systems, Inc.1985-12-05
REPLACEMENT PUMP TUBING (K853621)Shaban Mfg. Co.1985-12-05
PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT (K854324)Pantex, Div. Bio-Analysis, Inc.1985-12-05
LBK 1244 DELFIA HCG KIT (K852760)Lkb Instruments, Inc.1985-12-05
PARAGON ELECTROPHORESIS SYS LIPOPROTEIN REAGENT TE (K854057)Beckman Instruments, Inc.1985-12-05
IMMUCHEM V.I.P.(VISUAL INDICATED PREGNANCY) (K854104)Immunchem Corp.1985-12-05
ANALYZER NOVA STAT PROFILE 2/QUALITY CONTROL MAT. (K854608)Nova Biomedical Corp.1985-12-05
ELECTROLYTE ANALYZER SERA-252 (K853405)Horiba Instruments, Inc.1985-12-04
CK(OPTIMIZED) REAGENT (K854501)Sigma Diagnostics, Inc.1985-12-04
AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER (K854028)Verified Medical Research, Inc.1985-12-02
QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA (K853925)Nms Pharmaceuticals, Inc.1985-12-02
CORNING MAGIC MAB HCG RADIOIMMUNOASSAY (K854024)Corning Medical & Scientific1985-11-26
RAICHEM/K.E (K854540)Reagents Applications, Inc.1985-11-26
TECHNICON RA-500 SYSTEM (K854345)Technicon Instruments Corp.1985-11-26
ALT(OPTIMIZED) REAGENT (K854502)Sigma Diagnostics, Inc.1985-11-25
IN-VITRO TEST DETERMINATION TOTAL BILIRUBIN (K854180)Clinical Data, Inc.1985-11-25
IN-VITRO TEST FOR THE DETERMINATION OF CREATININE (K854178)Clinical Data, Inc.1985-11-25
IN-VITRO TEST DETERMINATION OF ALBUMIN (K854181)Clinical Data, Inc.1985-11-25
IN-VITRO TEST DETERMINATION OF URIC ACID (K854185)Clinical Data, Inc.1985-11-25
IN-VITRO TEST DETERMINATION OF TRIALYCERIDE (K854182)Clinical Data, Inc.1985-11-25
IN-VITRO TEST FOR THE DETERMINATION OF CHOLESTEROL (K854179)Clinical Data, Inc.1985-11-25
AST(OPTIMIZED) REAGENT (K854503)Sigma Diagnostics, Inc.1985-11-25
TDX CORTISOL (K854419)Abbott Laboratories1985-11-25
IN VITRO TEST DETERMINATION OF INORGANIC PHOSPHORO (K854188)Clinical Data, Inc.1985-11-25
IN-VITRO TEST DETERMINATION OF SGOT (AST) (K854187)Clinical Data, Inc.1985-11-25
ENZYMATIC TRIGLYCERIDES GPO-GRINDER METHOD (K854366)American Monitor Corp.1985-11-25
TOTAL PROTEIN (K854553)American Monitor Corp.1985-11-25
IN-VITRO TEST FOR THE DETERMINATION OF GLUCOSE (K854177)Clinical Data, Inc.1985-11-25
CALCITONIN RIA KIT (K854240)Diagnostic Systems Laboratories, Inc.1985-11-22
GLUCOSE REAGENT SET (GOD/TRINDER) (K854335)Sterling Diagnostics, Inc.1985-11-22
MR 700 MICROPLATE READER 012-700-1000 (K854303)Dynatech Laboratories, Inc.1985-11-19
I.C.L.S. COMPULYZER (K854055)Integrated Computerized Laboratory Systems, Inc.1985-11-19
ES 22 (K854243)Boehringer Mannheim Corp.1985-11-19
CHEMPRO 1000 (K854260)Sen Tech Medical Corp.1985-11-19
DOUBLE ANTIBODY C-PEPTIDE RIA KIT (K854066)Diagnostic Products Corp.1985-11-12
KODAKEKTACHEM DTR MODULE (K854138)Eastman Kodak Company1985-11-12
ANALYZER: NOVA STAT PROFILE 1 QUA CON MAT: ELECT (K852790)Nova Biomedical Corp.1985-11-12
DART IRON & IRON BINDING CAPACITY REAGENT (K854305)Coulter Electronics, Inc.1985-11-12
IRON (K854298)Boehringer Mannheim Corp.1985-11-12
TECHNICON RA SYSTEMS FOR TRIGLYCERIDES ANALYSIS IN (K854152)Technicon Instruments Corp.1985-11-05
ANTISERUM TO HUMAN APOLIPOPROTEIN B (K850690)Kent Laboratories, Inc.1985-11-01
ANTISERUM TO HUMAN APOLIPOPROTEIN A-I (K850691)Kent Laboratories, Inc.1985-11-01
ILEX PROMPT CLINICAL CHEMISTRY ANALYER (K853068)Ilex Corp.1985-10-31
DENTOCULT CULTURE-PADDLE (K851164)Orion Corp.1985-10-29
HITACHI 704 (K854025)Boehringer Mannheim Corp.1985-10-28
ASTRA SYSTEMS CHOLESTEROL REAGENT (K853854)Beckman Instruments, Inc.1985-10-28
SIGMA 610 FOR PROTEIN IN URINE & CSF (K853681)Sigma Diagnostics, Inc.1985-10-28
DMA CALIBRATORS (K854092)Data Medical Associates, Inc.1985-10-25
NML TSH IRMA (K854087)Organon Teknika Corp.1985-10-25
ACCURACY (K854119)Columbia Diagnostics, Inc.1985-10-25
BETA-TSH-IRMA (K853977)Leeco Diagnostics, Inc.1985-10-22
EDC/TITAN GELISO-TOTAL CPK ISOENZYME PROCEDURE (K852392)Helena Laboratories1985-10-22
DEMAND ACID PHOSPHATASE REAGENT (K853949)Cooper Biomedical, Inc.1985-10-16
LH/FSH RADIOIMMUNOASSAY KIT (K853837)Bioclinical Group1985-10-16
TDX AMYLASE (K853978)Abbott Laboratories1985-10-15
PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS (K853866)Pantex, Div. Bio-Analysis, Inc.1985-10-15
AMRESCO FLOW PAC CREATININE COLOR REAGENT 2310 & (K853888)American Research Products Co.1985-10-15
PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO (K853865)Pantex, Div. Bio-Analysis, Inc.1985-10-15
CANTROL URINE DIPSTICK CONTROL TWO LEVELS (K853603)Canyon Diagnostics, Inc.1985-10-08
LYTENING 1 (K853832)Amdev, Inc.1985-10-04
C-TERMINAL PTH RIA KIT (K853784)Diagnostic Systems Laboratories, Inc.1985-10-04
PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY (K853867)Pantex, Div. Bio-Analysis, Inc.1985-10-04
LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE) (K853906)Biodiagnostic Intl1985-10-04
QUANTIMETRIX HUMAN SERUM CHEMISTRY CONTROL (K853931)Quantimetrix Corp.1985-10-04
MYREADER 7 (K853284)Scientific Sales Intl., Inc.1985-10-04
VENTREZYME T3 IMMUNOASSAY T3 (K853703)Vxr, Inc.1985-10-04
QCA ENZYMATIC CHOLESTEROL (K853871)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-10-04
PREGNA/TEST (K853269)Modern Diagnostics, Inc.1985-10-03
TECHNICON CHEM 1 SYS ANALYTES MAGNESIUM GGT, URIC (K853853)Technicon Instruments Corp.1985-10-03
PHASE II B-12/FOLATE KIT (K853224)Medical & Scientific Designs, Inc.1985-10-03
BETA SCAN TRENDS METER (K851822)Orange Medical Instruments, Inc.1985-10-03
ALLEGRO TM HS-TSH IMMUNOASSAY SYSTEM (K853717)Nichols Institute Diagnostics1985-10-02
EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE (K852391)Helena Laboratories1985-10-01
BETA-HCG MICROTITER PREGNANCY TEST (K853258)Modern Diagnostics, Inc.1985-10-01
VENTRESCREEN HCG URINE (K853748)Vxr, Inc.1985-10-01
MULTIPURPOSE IMMUNOCHEMISTRY SYS-LA-2000 (K853391)Eiken Chemical Co., Inc.1985-10-01
LKB 4057 ULTROSPEC II E (K852538)Lkb Instruments, Inc.1985-09-30
URIC ACID(URICASE) FOR CONTINUOUS FLOW INSTRUMENTS (K853825)Catachem, Inc.1985-09-30
ALBUMIN SR LIQUID STABLE REAGENT SET (K853868)Medical Analysis Systems, Inc.1985-09-30
MR 650 MICROPLATE READER(CAT. NO. 011-973-0500) (K852411)Dynatech Laboratories, Inc.1985-09-30
GLUCOSE HEXOKINASE FOR CONTINUOUS FLOW INSTRUMENTS (K853826)Catachem, Inc.1985-09-30
LIQUI-SERA CHEM. MULTIPLE CALIBRATORS (K853887)Biodiagnostic Intl1985-09-30
BIO AUTOMED SYS CHEMISTRY ANALYZER AUTO-LOADER (K853453)Bio Automed Systems, Inc.1985-09-30
ABBOTT TESTPACK HCG(URINE) DIAGNOSTIC KIT (K853539)Abbott Laboratories1985-09-25
EASY ANALYZER & EASY-TEST REAGENT (K853699)Diagnostic Systems1985-09-25
APOLLO DENSITOMETER (K853734)Astral Medical Systems1985-09-25
SIMULTRAC FREE T4(57CO)/TSH[125I] RADIOIMMUNOASSAY (K853628)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-09-18
TDX REA BUN (K853677)Abbott Laboratories1985-09-16
FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM (K851450)Flow Cytometry Standards Corp.1985-09-16
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