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

    SERUM GLUTAMIC-PYRUVIC TRANSAMINASE

    K Number: K780507 · Decision May 3, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    23
    Review Days
    34

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    Basic Information

    Device Name
    SERUM GLUTAMIC-PYRUVIC TRANSAMINASE
    K Number
    K780507
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1030
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Gamma Enterprises, Inc.
    Date Received
    March 30, 1978
    Decision Date
    May 3, 1978
    Product Code
    CKC
    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
    CKC Vanillin Pyruvate, Alt/Sgpt

    Similar 510(k) Clearances

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    SERAYZER ALT/SGPT REAGENT STRIPS

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    Other Clearances by Gamma Enterprises, Inc.

    K Number Device Name
    K790578 GAMMA SMAC REAGENTS
    K780505 SERUM GLUTAMIC-OXALOACETIC-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. →