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

    REAGENT, Y-GT MAX-PACK

    K Number: K760366 · Decision Nov 1, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    32
    Applicant Total
    3
    Review Days
    89

    Basic Information

    Device Name
    REAGENT, Y-GT MAX-PACK
    K Number
    K760366
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1360
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Calbiochem
    Date Received
    August 4, 1976
    Decision Date
    November 1, 1976
    Product Code
    JPZ
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JPZ Colorimetric Method, Gamma-Glutamyl Transpeptidase

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