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

    ARCHITECT CA 15-3 ASSAY

    K Number: K042732 · Decision Dec 22, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    27
    Applicant Total
    45
    Review Days
    82

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    Basic Information

    Device Name
    ARCHITECT CA 15-3 ASSAY
    K Number
    K042732
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fujirebio Diagnostics,Inc.
    Date Received
    October 1, 2004
    Decision Date
    December 22, 2004
    Product Code
    MOI
    Advisory Committee
    Immunology
    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
    MOI System, Test, Immunological, Antigen, Tumor

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