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

    VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY

    K Number: K905636 · Decision Feb 7, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    265
    Applicant Total
    82
    Review Days
    52

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    Basic Information

    Device Name
    VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY
    K Number
    K905636
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5750
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Ventrex Laboratories, Inc.
    Date Received
    December 17, 1990
    Decision Date
    February 7, 1991
    Product Code
    DHB
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DHB System, Test, Radioallergosorbent (Rast) Immunological

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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
    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.
    K895649 COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN.
    Search all 82 clearances from Ventrex Laboratories, Inc. →