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

    TURBO-RAST SPECIFIC IGE ASSAY

    K Number: K904330 · Decision Dec 7, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    265
    Applicant Total
    82
    Review Days
    78

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    Basic Information

    Device Name
    TURBO-RAST SPECIFIC IGE ASSAY
    K Number
    K904330
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5750
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Ventrex Laboratories, Inc.
    Date Received
    September 20, 1990
    Decision Date
    December 7, 1990
    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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    K905612 VENTREX COATED TUBE IGE RADIOIMMUNOASSAY
    K905636 VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY
    K905247 SHBG IRMA KIT
    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.
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