BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Kit, Test, In Vitro Periodontal

    PMA: P870059 · Supplement: S001 · Decision Oct 16, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Kit, Test, In Vitro Periodontal
    Trade Name
    PERIOCHECK TM ENZYME ACTIVITY TEST KIT
    PMA Number
    P870059
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    MCL
    Generic Name
    KIT, TEST, IN VITRO PERIODONTAL
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 16, 1991
    Date Received
    September 6, 1991
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MCL Kit, Test, In Vitro Periodontal