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

    ASCENSIA DEX 2 DIABETES CARE SYSTEM

    K Number: K023584 · Decision Nov 20, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    178
    Same Product Code
    506
    Applicant Total
    96
    Review Days
    26

    Basic Information

    Device Name
    ASCENSIA DEX 2 DIABETES CARE SYSTEM
    K Number
    K023584
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BAYER CORP.
    Date Received
    October 25, 2002
    Decision Date
    November 20, 2002
    Product Code
    NBW
    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
    NBW System, Test, Blood Glucose, Over The Counter

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    Other Clearances by BAYER CORP.

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    K024234 ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL
    K022288 COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE 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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