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

    CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)

    K Number: K032027 · Decision Sep 5, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    4
    Applicant Total
    20
    Review Days
    66

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    Basic Information

    Device Name
    CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)
    K Number
    K032027
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1100
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cholestech Corp.
    Date Received
    July 1, 2003
    Decision Date
    September 5, 2003
    Product Code
    CIS
    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
    CIS Hydrazone Colorimetry, Ast/Sgot

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