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

    AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL

    K Number: K071580 · Decision Oct 3, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    138
    Applicant Total
    8
    Review Days
    117

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    Basic Information

    Device Name
    AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL
    K Number
    K071580
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1100
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Thermofisher Scientific OY
    Date Received
    June 8, 2007
    Decision Date
    October 3, 2007
    Product Code
    CIT
    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
    CIT Nadh Oxidation/Nad Reduction, Ast/Sgot

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    Other Clearances by Thermofisher Scientific OY

    K Number Device Name
    K110035 INDIKO
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    K073191 ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL
    K073355 CALCIUM, SCAL, NORTROL, ABTROL
    K070824 CREATININE (ENZYMATIC)
    K071340 CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL