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

    QM300 CALIBRATOR B PACK

    K Number: K875282 · Decision Feb 17, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    107
    Registration Numbers
    107
    Same Product Code
    301
    Applicant Total
    58
    Review Days
    55

    Basic Information

    Device Name
    QM300 CALIBRATOR B PACK
    K Number
    K875282
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    KALLESTAD DIAG, A DIV. OF ERBAMONT, INC.
    Date Received
    December 24, 1987
    Decision Date
    February 17, 1988
    Product Code
    JIX
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    IM
    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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