BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇳🇱 Netherlands

    EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM

    K Number: K131595 · Decision Jul 26, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    672
    Applicant Total
    7
    Review Days
    53

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    Basic Information

    Device Name
    EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM
    K Number
    K131595
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eurotrol B.V.
    Date Received
    June 3, 2013
    Decision Date
    July 26, 2013
    Product Code
    JJY
    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
    JJY Multi-Analyte Controls, All Kinds (Assayed)

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    Other Clearances by Eurotrol B.V.

    K Number Device Name
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    K152553 CueSee Hypoxic
    K121467 EUROTROL HEMATOCRIT CONTROL
    K121468 EUROTROL GAS-ISE METABOLITES
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