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

    SERACHEM PLUS CLINICAL CHEMISTRY CONTROLS

    K Number: K894852 · Decision Sep 28, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    672
    Applicant Total
    321
    Review Days
    59

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    Basic Information

    Device Name
    SERACHEM PLUS CLINICAL CHEMISTRY CONTROLS
    K Number
    K894852
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Instrumentation Laboratory CO
    Date Received
    July 31, 1989
    Decision Date
    September 28, 1989
    Product Code
    JJY
    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
    JJY Multi-Analyte Controls, All Kinds (Assayed)

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