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

    QUALITROL DHP IMMUNOASSAY CONTROL, LEVELS 1,2, AND 3

    K Number: K001249 · Decision Nov 2, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    672
    Applicant Total
    2
    Review Days
    204

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    Basic Information

    Device Name
    QUALITROL DHP IMMUNOASSAY CONTROL, LEVELS 1,2, AND 3
    K Number
    K001249
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Consolidated Technologies of Wisconsin
    Date Received
    April 12, 2000
    Decision Date
    November 2, 2000
    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 Consolidated Technologies of Wisconsin

    K Number Device Name
    K000810 QUALITROL LIPID CONTROL, LEVELS 1 AND 2