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

    SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE

    K Number: K780505 · Decision May 3, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    138
    Applicant Total
    23
    Review Days
    34

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    Basic Information

    Device Name
    SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE
    K Number
    K780505
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1100
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Gamma Enterprises, Inc.
    Date Received
    March 30, 1978
    Decision Date
    May 3, 1978
    Product Code
    CIT
    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
    CIT Nadh Oxidation/Nad Reduction, Ast/Sgot

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    Other Clearances by Gamma Enterprises, Inc.

    K Number Device Name
    K790578 GAMMA SMAC REAGENTS
    K780507 SERUM GLUTAMIC-PYRUVIC TRANSAMINASE
    K780504 CREATINE PHOSPHOKINASE (CPK)
    K780506 CARBON DIOXIDE REAGENTS
    K771843 WETTING AGENTS
    K771832 CHLORIDE
    K771836 LACTATE DEHYDROGENASE
    K771834 CREATININE
    K771838 SERUM IRON
    K771829 ALKALINE PHOSPHATASE
    Search all 23 clearances from Gamma Enterprises, Inc. →