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

    G-MARK

    K Number: K880076 · Decision Jul 1, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    8
    Applicant Total
    2
    Review Days
    172

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    Basic Information

    Device Name
    G-MARK
    K Number
    K880076
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3390
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Bainbridge Laboratories, Inc.
    Date Received
    January 11, 1988
    Decision Date
    July 1, 1988
    Product Code
    LIC
    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
    LIC Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae

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