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

    THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235

    K Number: K012525 · Decision Oct 4, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    248
    Applicant Total
    4
    Review Days
    59

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    Basic Information

    Device Name
    THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235
    K Number
    K012525
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    864.7470
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Thermo Dma, Inc.
    Date Received
    August 6, 2001
    Decision Date
    October 4, 2001
    Product Code
    LCP
    Advisory Committee
    Hematology
    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
    LCP Assay, Glycosylated Hemoglobin

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    Other Clearances by Thermo Dma, Inc.

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    K012518 TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113