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

    STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO.

    K Number: K860140 · Decision Feb 6, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    20
    Applicant Total
    149
    Review Days
    23

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    Basic Information

    Device Name
    STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO.
    K Number
    K860140
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    American Dade
    Date Received
    January 14, 1986
    Decision Date
    February 6, 1986
    Product Code
    LAN
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LAN Enzyme Immunoassay, N-Acetylprocainamide

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