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

    ALLERGENETICS IGE-FAST TEST

    K Number: K822341 · Decision Nov 10, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    113
    Applicant Total
    8
    Review Days
    98

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    Basic Information

    Device Name
    ALLERGENETICS IGE-FAST TEST
    K Number
    K822341
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Allergenetics
    Date Received
    August 4, 1982
    Decision Date
    November 10, 1982
    Product Code
    DGC
    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
    DGC Ige, Antigen, Antiserum, Control

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    K842969 ALLERGENETICS ALLER-SPECIFIC IGE SERUM
    K833418 CHYMOFAST TEST
    K834594 TOTAL IGE FAST TEST
    K833419 LABELED 125I ANTI-IGE
    K834244 THEOFAST TEST KIT FOR QUANTITATIVE THEO