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

    DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM

    K Number: K972580 · Decision Sep 22, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    20
    Applicant Total
    96
    Review Days
    74

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    Basic Information

    Device Name
    DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
    K Number
    K972580
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1400
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bayer Corp.
    Date Received
    July 10, 1997
    Decision Date
    September 22, 1997
    Product Code
    JMM
    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
    JMM Column Chromatography & Color Development, Hydroxyproline

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