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

    BACTON(TM), AUTO-APO B REAGENT

    K Number: K921862 · Decision Jun 22, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    49
    Applicant Total
    2
    Review Days
    69

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    Basic Information

    Device Name
    BACTON(TM), AUTO-APO B REAGENT
    K Number
    K921862
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1475
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bacton Assay Systems, Inc.
    Date Received
    April 14, 1992
    Decision Date
    June 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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    Other Clearances by Bacton Assay Systems, Inc.

    K Number Device Name
    K921795 BACTON(TM), AUTO-APO A-1 REAGENT