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

    LIQUID ASSAYED TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3

    K Number: K944525 · Decision Mar 21, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135
    Same Product Code
    672
    Applicant Total
    107
    Review Days
    186

    Basic Information

    Device Name
    LIQUID ASSAYED TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3
    K Number
    K944525
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    MEDICAL ANALYSIS SYSTEMS, INC.
    Date Received
    September 16, 1994
    Decision Date
    March 21, 1995
    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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