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Clinical Chemistry

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

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RecordFirmDate
CHOLESTEROL AQUEOUS STANDARD (K840217)Preventive Diagnostics Corp.1984-03-23
DPC ACTH KIT (K840018)Diagnostic Products Corp.1984-03-23
PH ELECTRODE CALIBRATING BUFFERS-BLOOD (K840299)Bionostics, Inc.1984-03-23
COAT-A-COUNT ESTRADIOL KIT (K840051)Diagnostic Products Corp.1984-03-23
TRIGLYCERIDE/CHOLESTEROL AQUEOUS (K840219)Preventive Diagnostics Corp.1984-03-23
KINETIC LDH, A< BLUE 610 METHOD (K840006)American Monitor Corp.1984-03-23
MICROMEDIC LH & FSH RIA KIT (K840188)Micromedic Systems1984-03-23
TOTAL CHOLESTEROL REAGENT SET (K840189)Preventive Diagnostics Corp.1984-03-23
FSH QUIK RIA KIT (K840230)Pacific Biotech, Inc.1984-03-23
ACE COLOR TEST (K833933)Hana Biologics, Inc.1984-03-23
CHEM-STAT ANALYZER (K840340)Ocean Scientific, Inc.1984-03-23
FLUSH SOLUTION CONCENTRATE-BLOOD GAS (K840300)Bionostics, Inc.1984-03-23
UNI-FAST ANALYZER SYSTEM (K840129)Sclavo, Inc.1984-03-23
ADVANTAGE (K840120)Gilford1984-03-23
ORTHO BI-LEVEL RECEPTOR CONTROL (K834064)Ortho Diagnostic Systems, Inc.1984-03-23
DISPOSABLE CUVETTE ARRAY (K840231)Consumable Lab Supplies1984-03-22
EKTACHEM CLINICAL CHEM. SLIDES (K840151)Eastman Kodak Company1984-03-22
VERIFY PREGNANCY TEST KIT (K840602)O.T.C. Diagnostics, Inc.1984-03-19
SOPHEIA T3 EIA KIT (K840050)Diagnostic Products Corp.1984-03-19
CALCIUM REAGENT SYS (K840214)Sclavo, Inc.1984-03-19
ACCUFLEX (K834590)Micromedic Systems1984-03-19
TOTAL BILIRUBIN (K840111)Fisher Scientific Co., LLC1984-03-19
LH QUIK RIA KIT (K840174)Pacific Biotech, Inc.1984-03-19
SODIUM/POTASSIUM REAGENT SYS (K840216)Sclavo, Inc.1984-03-19
HCG RIA (K833851)Syncor Intl. Corp.1984-03-19
PHOSPHORUS REAGENT SYSTEM (K840215)Sclavo, Inc.1984-03-19
BLOOD UREA NITROGEN REAGENT SYS (K840213)Sclavo, Inc.1984-03-19
CORNING 4000 MULTI-WELL GAMMA COUNTER (K834508)Corning Medical & Scientific1984-03-16
TITAN GEL LIPOPROTEIN ELECTROPHORESIS (K833611)Helena Laboratories1984-03-15
RA-1000 SYS-T4(THYROXINE)SERUM ANAL (K834102)Technicon Instruments Corp.1984-03-15
TOTAL IRON UIBC/TIBC ASSAY (K840485)Somas Medical Industries, Inc.1984-03-12
APSARA ANALYZER (K834534)Datachem, Inc.1984-03-09
LIQUI ZYME TOTAL BILIRUBIN REAGENT (K840564)American Research Products Co.1984-03-09
SDI PREPAX DILUKIT 29-1000 (K840044)Scientific Distributors, Inc.1984-03-09
PARAMAX ALANINE AMINOTRANSFERASE (K840705)American Dade1984-03-09
TRI-TUBE RIA (K840589)Nuclear Medical Laboratories, Inc.1984-03-09
LEECO E2 QUANT DIAG. TEST KIT (K834586)Leeco Diagnostics, Inc.1984-03-09
STRATUS THYROID UPTAKE FLUOROMETRIC (K834209)American Dade1984-03-09
AVL MODEL 945 BLOOD GAS SYSTEM (K834601)Avl Scientific Corp.1984-03-09
STRATUS TOTAL THYROXINE FLUOROMETRIC (K834210)American Dade1984-03-05
ALDOSTERONE RADIOIMMUNOASSAY TEST KIT (K834428)Serono Laboratories, Inc.1984-03-02
LIQUID STABLE TRIGLYCERIDES REAGENT SET (K834518)Medical Analysis Systems, Inc.1984-03-02
TITAN GEL SILVER STAIN SYSTEM (K833855)Helena Laboratories1984-02-27
CK-NAC REAGENT (K834502)Roche Diagnostic Systems, Inc.1984-02-27
DISCRETE CLINICAL ANALYZER (K834521)E.I. Dupont DE Nemours & Co., Inc.1984-02-27
FLOW-PAC CALCIUM REAGENT SET (K834336)American Research Products Co.1984-02-21
FLOW-PAC CHLORIDE REAGENT SET (K834333)American Research Products Co.1984-02-21
LEECO T3-QUANT DIAG. KIT (K834348)Leeco Diagnostics, Inc.1984-02-21
PRE-CALIBRATED PIPETTES (K834100)Vitex1984-02-21
DIRECT IRON REAGENT SET (K834396)Seragen Diagnostics, Inc.1984-02-21
HYBRITECH DATA STATION (K834300)Hybritech, Inc.1984-02-21
HDL CHOLESTEROL PRETREATMENT (K834251)American Monitor Corp.1984-02-13
REFLOCHECK & GLUCOSE TEST STRIP SYS (K834271)Boehringer Mannheim Corp.1984-02-13
ULTROSPEC W/APPLE II -4050- (K834489)Lkb Instruments, Inc.1984-02-10
HDL EZ-TAB (K833160)Preventive Diagnostics Corp.1984-02-09
HYDROXYBUTYRATE DEHYDROGENASE REAGENT (K834084)Sterling Biochemical, Inc.1984-02-04
RADIOIMMUNOASSAY, THYROID STIMU. HORMONE (K833193)Biosan Laboratories, Inc.1984-02-04
DART GAMMA-GT REAGENT SYSTEM (K834054)Coulter Electronics, Inc.1984-02-04
PROGESTERONE TEST SET 125I 17-OH (K834246)Wien Laboratories, Inc.1984-02-04
T3 RIA (K833853)Syncor Intl. Corp.1984-02-04
PHASE II CORTISOL KIT (K834219)Medical & Scientific Designs, Inc.1984-02-04
DART ALPHA-AMYLASE REAGENT SYSTEM (K834053)Coulter Electronics, Inc.1984-02-04
BHCG-CHECK (K834346)Diagnostic Technology, Inc.1984-02-04
TANDEM VISUAL HCG IMMUNOENZYMETRIC (K834000)Hybritech, Inc.1984-02-03
VENTREX PREGNANCY TEST KIT ENZYME (K833960)Vxr, Inc.1984-02-03
QUALITATIVE ENZYME IMMUNOASSAY-DETECT (K832905)Btc Diagnostics, Inc.1984-02-03
BLOOD GLUCOSE MONITOR (K834099)Healthdyne, Inc.1984-02-03
FERTITUBE PREGNANCY TEST #1120 (K832867)Stanbio Laboratory1984-02-03
MAGNESIUM B TEST (K834075)Wako Chemicals USA, Inc.1984-02-03
PARALLEL FLAME PHOTOMETER & SODIUM (K834248)American Monitor Corp.1984-01-30
RIANEN FOLLICLE STIMULATING HORMONE (K834038)New England Nuclear1984-01-30
ACA THYROXINE UPTAKE ANALYTICAL TEST (K833703)E.I. Dupont DE Nemours & Co., Inc.1984-01-30
QCA CHEMISTRY ANALYZER (K833998)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-01-30
ANTIBODY TO INTRINSIC FACTOR RADIOASSAY (K833142)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-01-30
DPC GASTRIN KIT (K833489)Diagnostic Products Corp.1984-01-30
ACTH RIA (K833849)Syncor Intl. Corp.1984-01-30
URIC ACID REAGENT SET (K834045)Sterling Biochemical, Inc.1984-01-30
ANGIOTENSIN CONVERTING ENZYME (K833777)Immuno-Diagnostic Laboratories1984-01-30
KINETIC ALKALINE PHOSPHATASE (K834033)American Monitor Corp.1984-01-30
BTC URINE LH ASSAY (K833710)Btc Diagnostics, Inc.1984-01-30
CENTRICON MICRO-CONCENTRATOR (K833919)Amicon, Inc.1984-01-30
ENDAB T3 (K834049)Immunotech Corp.1984-01-30
STAR HCG MONOCLONAL ANTIBODY IMMUNORAD (K832796)Syncor Intl. Corp.1984-01-24
TECHNICON RA-1000 SYSTEM (K833992)Technicon Instruments Corp.1984-01-24
MICROLAB M DILUTER/DISPENSER (K833959)Syva Co.1984-01-24
IMMOPHASE D-TE 3 RADIOIMMUNOASSAY (K833406)Corning Medical & Scientific1984-01-24
COAT-A-COUNT NHS-PROLACTIN KIT AND (K833925)Diagnostic Products Corp.1984-01-24
LABORATORY DATA MGMT SYSTEM SDMS (K831838)Vickers America Medical Corp.1984-01-24
BIO-SCIENCE LABORATORIES T4 REAGENT (K834023)Biosan Laboratories, Inc.1984-01-24
CHLORIDE REAGENT SET (K832438)Amresco, Inc.1984-01-20
ORTHO B-HCG SLIDE TEST FOR PREGNANCY (K833137)Ortho Diagnostic Systems, Inc.1984-01-18
DURAZYME CPK (K833781)American Monitor Corp.1984-01-18
T4 RIA (K833850)Syncor Intl. Corp.1984-01-18
ACID BASE LABORATORY ABL4 (K833696)Radiometer America, Inc.1984-01-18
TANDEM R-TOTAL B-GCG KIT (K833194)Hybritech, Inc.1984-01-18
KODAK EKTACHEM 700 ANALYZER (K833833)Eastman Kodak Company1984-01-17
CREATININE REAGENT SET (K832439)Amresco, Inc.1984-01-17
AMYLASE REAGENT SET-MODIFIED CARAWAY (K833864)Sterling Biochemical, Inc.1984-01-13
FSH RIA (K833852)Syncor Intl. Corp.1984-01-13
NA/K FLUIDA PACK FOR NOVA 1 ANALYZER (K833712)Fisher Scientific Co., LLC1984-01-13
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