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

    HERPES IDENT. & TYPING TEST HITT

    K Number: K831504 · Decision Sep 20, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    36
    Applicant Total
    41
    Review Days
    132

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    Basic Information

    Device Name
    HERPES IDENT. & TYPING TEST HITT
    K Number
    K831504
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Electro-Nucleonics Laboratories, Inc.
    Date Received
    May 11, 1983
    Decision Date
    September 20, 1983
    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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