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

    DMA GLUCOSE HEXOKINASE U.V. PROCEDURE

    K Number: K952437 · Decision Oct 3, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    144
    Applicant Total
    111
    Review Days
    131

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    Basic Information

    Device Name
    DMA GLUCOSE HEXOKINASE U.V. PROCEDURE
    K Number
    K952437
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Data Medical Associates, Inc.
    Date Received
    May 25, 1995
    Decision Date
    October 3, 1995
    Product Code
    CFR
    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
    CFR Hexokinase, Glucose

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    Other Clearances by Data Medical Associates, Inc.

    K Number Device Name
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    K955302 SERUM BICARBONATE/CARBON DIOXIDE
    K955796 IRON CALIBRATOR & CALIBRATION VERIFICATION SET
    K955300 TOTAL BILIRUBIN PROCEDURE
    K946161 DMA TOTAL CHOLESTEROL PROCEDURE
    K946354 DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE
    K946355 DMA ALBUMIN PROCEDURE
    K944255 DMA CALCIUM PLUS PROCEDURE
    Search all 111 clearances from Data Medical Associates, Inc. →