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

    MODIFICATION TO MYALLERGY TEST

    K Number: K061979 · Decision Sep 22, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    4
    Review Days
    71

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    Basic Information

    Device Name
    MODIFICATION TO MYALLERGY TEST
    K Number
    K061979
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Immunetech Corporation
    Date Received
    July 13, 2006
    Decision Date
    September 22, 2006
    Product Code
    JKA
    Advisory Committee
    Clinical Chemistry
    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
    JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

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    Other Clearances by Immunetech Corporation

    K Number Device Name
    K032251 IMMUNETECH TOTAL IGE SYSTEM
    K021698 MY ALLERGY TEST
    K020387 MYALLERGYTEST SYSTEM