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

    APOLIPOPROTEIN TEST SYSTEM

    K Number: K921037 · Decision May 22, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    49
    Applicant Total
    72
    Review Days
    79

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    Basic Information

    Device Name
    APOLIPOPROTEIN TEST SYSTEM
    K Number
    K921037
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1475
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Baxter Diagnostics, Inc.
    Date Received
    March 4, 1992
    Decision Date
    May 22, 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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    K941030 DRIED GRAM-NEGATIVE CEFPODOXIME
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    K941317 DRIED GRAM NEGATIVE/CEFMETAZOLE
    K942089 MICRODILUTION/LORACARBEF PANELS
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