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

    ACE COLOR TEST

    K Number: K833933 · Decision Mar 23, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    7
    Applicant Total
    8
    Review Days
    130

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    Basic Information

    Device Name
    ACE COLOR TEST
    K Number
    K833933
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1090
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Hana Biologics, Inc.
    Date Received
    November 14, 1983
    Decision Date
    March 23, 1984
    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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