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

    CROSSLAPS ELISA

    K Number: K972788 · Decision Dec 22, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    20
    Applicant Total
    1
    Review Days
    512

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    Basic Information

    Device Name
    CROSSLAPS ELISA
    K Number
    K972788
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1400
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Devices and Diagnostics Consulting Group
    Date Received
    July 28, 1997
    Decision Date
    December 22, 1998
    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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