BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DMA MICROPROTEIN PROCEDURE

    K Number: K890868 · Decision Mar 20, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    115
    Applicant Total
    111
    Review Days
    27

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    Basic Information

    Device Name
    DMA MICROPROTEIN PROCEDURE
    K Number
    K890868
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1635
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Data Medical Associates, Inc.
    Date Received
    February 21, 1989
    Decision Date
    March 20, 1989
    Product Code
    CEK
    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
    CEK Biuret (Colorimetric), Total Protein

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    Other Clearances by Data Medical Associates, Inc.

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    K955302 SERUM BICARBONATE/CARBON DIOXIDE
    K955796 IRON CALIBRATOR & CALIBRATION VERIFICATION SET
    K955300 TOTAL BILIRUBIN PROCEDURE
    K952437 DMA GLUCOSE HEXOKINASE U.V. PROCEDURE
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