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

    MODIFICATION TO N PROTEIN STANDARD SL

    K Number: K012470 · Decision Sep 28, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    107
    Registration Numbers
    107
    Same Product Code
    301
    Applicant Total
    343
    Review Days
    57

    Basic Information

    Device Name
    MODIFICATION TO N PROTEIN STANDARD SL
    K Number
    K012470
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DADE BEHRING, INC.
    Date Received
    August 2, 2001
    Decision Date
    September 28, 2001
    Product Code
    JIX
    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
    JIX Calibrator, Multi-Analyte Mixture

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