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

    IL TEST APOLIPOROTEIN B (APO B)

    K Number: K923080 · Decision Oct 26, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    49
    Applicant Total
    321
    Review Days
    123

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    Basic Information

    Device Name
    IL TEST APOLIPOROTEIN B (APO B)
    K Number
    K923080
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1475
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Instrumentation Laboratory CO
    Date Received
    June 25, 1992
    Decision Date
    October 26, 1992
    Product Code
    MSJ
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MSJ Apolipoproteins

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