BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇮 Finland

    UREA/BUN, SCAL, NORTROL, ABTROL

    K Number: K073295 · Decision May 29, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    116
    Applicant Total
    8
    Review Days
    188

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    Basic Information

    Device Name
    UREA/BUN, SCAL, NORTROL, ABTROL
    K Number
    K073295
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1770
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Thermofisher Scientific OY
    Date Received
    November 23, 2007
    Decision Date
    May 29, 2008
    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 Thermofisher Scientific OY

    K Number Device Name
    K110035 INDIKO
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    K073355 CALCIUM, SCAL, NORTROL, ABTROL
    K070824 CREATININE (ENZYMATIC)
    K071340 CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL
    K071580 AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL