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

    ENZYMUN-TEST(R) IGE

    K Number: K863822 · Decision Oct 29, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    113
    Applicant Total
    340
    Review Days
    29

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    Basic Information

    Device Name
    ENZYMUN-TEST(R) IGE
    K Number
    K863822
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Boehringer Mannheim Corp.
    Date Received
    September 30, 1986
    Decision Date
    October 29, 1986
    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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