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

    ALLERGENETICS ALLER-SPECIFIC IGE SERUM

    K Number: K842969 · Decision Aug 28, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    3
    Applicant Total
    8
    Review Days
    29

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    Basic Information

    Device Name
    ALLERGENETICS ALLER-SPECIFIC IGE SERUM
    K Number
    K842969
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Allergenetics
    Date Received
    July 30, 1984
    Decision Date
    August 28, 1984
    Product Code
    DGP
    Advisory Committee
    Immunology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DGP Ige, Fitc, Antigen, Antiserum, Control

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    Other Clearances by Allergenetics

    K Number Device Name
    K851512 ALLERGENETICS IGE FAST TEST
    K842970 ALLERGENTICS TOTAL IGE/THEOPHYLLINE
    K833418 CHYMOFAST TEST
    K834594 TOTAL IGE FAST TEST
    K833419 LABELED 125I ANTI-IGE
    K834244 THEOFAST TEST KIT FOR QUANTITATIVE THEO
    K822341 ALLERGENETICS IGE-FAST TEST