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

    Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge

    K Number: K053110 · Decision Jan 13, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    161
    Applicant Total
    7
    Review Days
    70

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    Basic Information

    Device Name
    Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge
    K Number
    K053110
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.1665
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    I-Stat Corporation
    Date Received
    November 4, 2005
    Decision Date
    January 13, 2006
    Product Code
    JGS
    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
    JGS Electrode, Ion Specific, Sodium

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    Other Clearances by I-Stat Corporation

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    K023582 I-STAT KAOLIN ACT TEST
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    K020355 I-STAT PROTHROMBIN TIME TEST