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

    ALTLTS ALANINE AMINO TRANSFERASE ALT

    K Number: K883205 · Decision Sep 9, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    126
    Applicant Total
    9
    Review Days
    43

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    Basic Information

    Device Name
    ALTLTS ALANINE AMINO TRANSFERASE ALT
    K Number
    K883205
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1030
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Electro-Nucleonics, Inc.
    Date Received
    July 28, 1988
    Decision Date
    September 9, 1988
    Product Code
    CKA
    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
    CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt

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