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

    EASYRA UREA NITROGEN AND CREATININE REAGENTS

    K Number: K110675 · Decision Apr 21, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    116
    Applicant Total
    47
    Review Days
    42

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    Basic Information

    Device Name
    EASYRA UREA NITROGEN AND CREATININE REAGENTS
    K Number
    K110675
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1770
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medica Corp.
    Date Received
    March 10, 2011
    Decision Date
    April 21, 2011
    Product Code
    CDQ
    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
    CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen

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    Other Clearances by Medica Corp.

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    K111363 PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL
    K111005 ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL
    K112788 EASTLYTE NA/K/CA/PH
    K101089 EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR
    K101090 EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS
    K101088 EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT
    K100829 EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520
    K092116 EASYCELL CELL LOCATOR
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