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

    DOCUMENT THYROID CAL*VER

    K Number: K992034 · Decision Jul 23, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    672
    Applicant Total
    3
    Review Days
    37

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    Basic Information

    Device Name
    DOCUMENT THYROID CAL*VER
    K Number
    K992034
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Casco-Nerl Diagnostics Corporation (Maine)
    Date Received
    June 16, 1999
    Decision Date
    July 23, 1999
    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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    Other Clearances by Casco-Nerl Diagnostics Corporation (Maine)

    K Number Device Name
    K002174 DOCUMENT ASSAYED CHEMISTRY CONTROL, LEVELS 1, 2 AND3
    K993014 MODIFICATION TO DOCUMENT THYROID CAL.VER