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

    DATAPRO CLINICAL CHELISTRY ANALYZER

    K Number: K042767 · Decision Apr 27, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    144
    Applicant Total
    2
    Review Days
    204

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    Basic Information

    Device Name
    DATAPRO CLINICAL CHELISTRY ANALYZER
    K Number
    K042767
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Thermo Electron Corporation
    Date Received
    October 5, 2004
    Decision Date
    April 27, 2005
    Product Code
    CFR
    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
    CFR Hexokinase, Glucose

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    Other Clearances by Thermo Electron Corporation

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