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

    DUPONT ACALACTIC ACID (LA) TEST

    K Number: K802064 · Decision Sep 26, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    26
    Applicant Total
    253
    Review Days
    30

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    Basic Information

    Device Name
    DUPONT ACALACTIC ACID (LA) TEST
    K Number
    K802064
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1450
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    August 27, 1980
    Decision Date
    September 26, 1980
    Product Code
    KHP
    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
    KHP Acid, Lactic, Enzymatic Method

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