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

    BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)

    K Number: K982328 · Decision Jan 29, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    96
    Review Days
    211

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    Basic Information

    Device Name
    BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
    K Number
    K982328
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1050
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bayer Corp.
    Date Received
    July 2, 1998
    Decision Date
    January 29, 1999
    Product Code
    CJO
    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
    CJO Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes

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    K024234 ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL
    K022288 COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
    K023584 ASCENSIA DEX 2 DIABETES CARE SYSTEM
    K020828 CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM
    K021428 CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM
    K020806 ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY
    K013568 CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
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