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

    HDL CHOLESTEROL PRECIPITATING PROCEDURE

    K Number: K881326 · Decision May 27, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    65
    Applicant Total
    111
    Review Days
    59

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    Basic Information

    Device Name
    HDL CHOLESTEROL PRECIPITATING PROCEDURE
    K Number
    K881326
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1475
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Data Medical Associates, Inc.
    Date Received
    March 29, 1988
    Decision Date
    May 27, 1988
    Product Code
    LBR
    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
    LBR Ldl & Vldl Precipitation, Hdl

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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. →