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

    LACTATE DEHYDROGENASE(LD) PROCEDURE

    K Number: K863255 · Decision Oct 3, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    110
    Applicant Total
    111
    Review Days
    39

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    Basic Information

    Device Name
    LACTATE DEHYDROGENASE(LD) PROCEDURE
    K Number
    K863255
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1440
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Data Medical Associates, Inc.
    Date Received
    August 25, 1986
    Decision Date
    October 3, 1986
    Product Code
    CFJ
    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
    CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

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    K955302 SERUM BICARBONATE/CARBON DIOXIDE
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    K955300 TOTAL BILIRUBIN PROCEDURE
    K952437 DMA GLUCOSE HEXOKINASE U.V. PROCEDURE
    K946161 DMA TOTAL CHOLESTEROL PROCEDURE
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