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

    SYSTEMATE GOT 67208

    K Number: K843333 · Decision Sep 20, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    138
    Applicant Total
    288
    Review Days
    24

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    Basic Information

    Device Name
    SYSTEMATE GOT 67208
    K Number
    K843333
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1100
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Em Diagnostic Systems, Inc.
    Date Received
    August 27, 1984
    Decision Date
    September 20, 1984
    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 Em Diagnostic Systems, Inc.

    K Number Device Name
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    K935179 EMDS ALBUMIN (ALB) TEST
    K935174 TOTAL PROTEIN TEST (TPRO)
    K935177 GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST
    K935136 CHOLESTEROL (CHOL) TEST ITEM NO. 65410
    K935175 LACTATE DEHYDROGENASE (LD)
    K935176 IRON TEST
    K935183 EMDS MAGNESIUM (MG) TEST
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