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

    EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT

    K Number: K123802 · Decision Mar 1, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    234
    Applicant Total
    47
    Review Days
    81

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    Basic Information

    Device Name
    EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT
    K Number
    K123802
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1110
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medica Corp.
    Date Received
    December 10, 2012
    Decision Date
    March 1, 2013
    Product Code
    CIG
    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
    CIG Diazo Colorimetry, Bilirubin

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    K100829 EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520
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