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

    REAGENT, VDRL

    K Number: K760098 · Decision Aug 3, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    8
    Applicant Total
    21
    Review Days
    50

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    Basic Information

    Device Name
    REAGENT, VDRL
    K Number
    K760098
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3830
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Gamma Biologicals, Inc.
    Date Received
    June 14, 1976
    Decision Date
    August 3, 1976
    Product Code
    GMT
    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
    GMT Antigens, Ha, Treponema Pallidum

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