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

    BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY

    K Number: K913091 · Decision Aug 26, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    7
    Applicant Total
    27
    Review Days
    45

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    Basic Information

    Device Name
    BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY
    K Number
    K913091
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1090
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    American Laboratory Products Co., Ltd.
    Date Received
    July 12, 1991
    Decision Date
    August 26, 1991
    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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