BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    IMMUNO-TEC II OT AGAROSE PLATE KIT

    K Number: K761270 · Decision Dec 30, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    145
    Review Days
    14

    Basic Information

    Device Name
    IMMUNO-TEC II OT AGAROSE PLATE KIT
    K Number
    K761270
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.4600
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    BEHRING DIAGNOSTICS, INC.
    Date Received
    December 16, 1976
    Decision Date
    December 30, 1976
    Product Code
    JZP
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JZP Plates, Ouchterlony Agar

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