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

    ULTRAZYME PLUS & SYSTEMATE LDH

    K Number: K854585 · Decision Dec 5, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    110
    Applicant Total
    288
    Review Days
    17

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    Basic Information

    Device Name
    ULTRAZYME PLUS & SYSTEMATE LDH
    K Number
    K854585
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1440
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Em Diagnostic Systems, Inc.
    Date Received
    November 18, 1985
    Decision Date
    December 5, 1985
    Product Code
    CFJ
    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
    CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

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    Other Clearances by Em Diagnostic Systems, Inc.

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    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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