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

    ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY

    K Number: K993706 · Decision Jul 24, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    20
    Applicant Total
    264
    Review Days
    265

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    Basic Information

    Device Name
    ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY
    K Number
    K993706
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1400
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Diagnostics Corp.
    Date Received
    November 2, 1999
    Decision Date
    July 24, 2000
    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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