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

    DMA CALCIUM PLUS PROCEDURE

    K Number: K944255 · Decision Dec 6, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    46
    Applicant Total
    111
    Review Days
    96

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    Basic Information

    Device Name
    DMA CALCIUM PLUS PROCEDURE
    K Number
    K944255
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1145
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Data Medical Associates, Inc.
    Date Received
    September 1, 1994
    Decision Date
    December 6, 1994
    Product Code
    CJY
    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
    CJY Azo Dye, Calcium

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    Other Clearances by Data Medical Associates, Inc.

    K Number Device Name
    K993098 HDL-C/LDL-C CALIBRATOR, MODEL 1913-003
    K971113 DMA TRIGLYCERIDES PROCEDURES
    K961919 DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE
    K955302 SERUM BICARBONATE/CARBON DIOXIDE
    K955796 IRON CALIBRATOR & CALIBRATION VERIFICATION SET
    K955300 TOTAL BILIRUBIN PROCEDURE
    K952437 DMA GLUCOSE HEXOKINASE U.V. PROCEDURE
    K946161 DMA TOTAL CHOLESTEROL PROCEDURE
    K946354 DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE
    K946355 DMA ALBUMIN PROCEDURE
    Search all 111 clearances from Data Medical Associates, Inc. →