BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    LD1 ISOENZYME REAGENT KIT

    K Number: K890996 · Decision May 5, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    55
    Review Days
    67

    Basic Information

    Device Name
    LD1 ISOENZYME REAGENT KIT
    K Number
    K890996
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1445
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    TRACE SCIENTIFIC LTD.
    Date Received
    February 27, 1989
    Decision Date
    May 5, 1989
    Product Code
    JGF
    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
    JGF Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes

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