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

    THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT

    K Number: K041657 · Decision Aug 30, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    73

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    Basic Information

    Device Name
    THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT
    K Number
    K041657
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1090
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Thermo Electron Corporation
    Date Received
    June 18, 2004
    Decision Date
    August 30, 2004
    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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