BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT

    K Number: K043378 · Decision Dec 29, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    244
    Applicant Total
    7
    Review Days
    21

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    Basic Information

    Device Name
    DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT
    K Number
    K043378
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Drew Scientific , Ltd.
    Date Received
    December 8, 2004
    Decision Date
    December 29, 2004
    Product Code
    JIT
    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
    JIT Calibrator, Secondary

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