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

    ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219

    K Number: K981864 · Decision Jun 12, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    280
    Registration Numbers
    280
    Same Product Code
    492
    Applicant Total
    199
    Review Days
    16

    Basic Information

    Device Name
    ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219
    K Number
    K981864
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BECKMAN COULTER, INC.
    Date Received
    May 27, 1998
    Decision Date
    June 12, 1998
    Product Code
    JJX
    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
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

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