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

    ANGIOTENSIN CONVERTING ENZYME ASSAY SYS

    K Number: K791712 · Decision Sep 19, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    7
    Applicant Total
    82
    Review Days
    50

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    Basic Information

    Device Name
    ANGIOTENSIN CONVERTING ENZYME ASSAY SYS
    K Number
    K791712
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1090
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Ventrex Laboratories, Inc.
    Date Received
    July 31, 1979
    Decision Date
    September 19, 1979
    Product Code
    KQN
    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
    KQN Radioassay, Angiotensin Converting Enzyme

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