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

    DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST

    K Number: K851635 · Decision Oct 10, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    36
    Applicant Total
    6
    Review Days
    175

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    Basic Information

    Device Name
    DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST
    K Number
    K851635
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Diagnon Corp.
    Date Received
    April 18, 1985
    Decision Date
    October 10, 1985
    Product Code
    GQL
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GQL Antisera, Fluorescent, Herpesvirus Hominis 1,2

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