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

    CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772

    K Number: K991834 · Decision Sep 9, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    10
    Applicant Total
    20
    Review Days
    104

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    Basic Information

    Device Name
    CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772
    K Number
    K991834
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1030
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cholestech Corp.
    Date Received
    May 28, 1999
    Decision Date
    September 9, 1999
    Product Code
    CKD
    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
    CKD Hydrazone Colorimetry, Alt/Sgpt

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