BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    VENTRE/SEP DIGOXIN RADIOIMMUNOASSAY KIT

    K Number: K791355 · Decision Aug 10, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    13
    Applicant Total
    82
    Review Days
    20

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    Basic Information

    Device Name
    VENTRE/SEP DIGOXIN RADIOIMMUNOASSAY KIT
    K Number
    K791355
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Ventrex Laboratories, Inc.
    Date Received
    July 21, 1979
    Decision Date
    August 10, 1979
    Product Code
    DPO
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DPO Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.

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    Other Clearances by Ventrex Laboratories, Inc.

    K Number Device Name
    K914554 SPECIFIC IGE EIA-TURBO ASSAY
    K913833 VENTREX ALLERGEN DISC
    K913434 VENTREX COATED TUBE INTACT PTH
    K905612 VENTREX COATED TUBE IGE RADIOIMMUNOASSAY
    K905636 VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY
    K905247 SHBG IRMA KIT
    K904330 TURBO-RAST SPECIFIC IGE ASSAY
    K903000 TURBO-RAST SPECIFIC IGE ASSAY
    K897083 VENTRESIGN STREP A TEST
    K895648 COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN.
    Search all 82 clearances from Ventrex Laboratories, Inc. →