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

    DOCUMENT(TM) IRON MAGNESIUM LINEARITY TEST SET

    K Number: K893141 · Decision Jun 23, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135
    Same Product Code
    672
    Applicant Total
    38
    Review Days
    59

    Basic Information

    Device Name
    DOCUMENT(TM) IRON MAGNESIUM LINEARITY TEST SET
    K Number
    K893141
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    CASCO STANDARDS
    Date Received
    April 25, 1989
    Decision Date
    June 23, 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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