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

    PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS

    K Number: K063145 · Decision Oct 17, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    43
    Applicant Total
    9
    Review Days
    366

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    Basic Information

    Device Name
    PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS
    K Number
    K063145
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3350
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Thermo Electron OY
    Date Received
    October 16, 2006
    Decision Date
    October 17, 2007
    Product Code
    DIP
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DIP Enzyme Immunoassay, Diphenylhydantoin

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    Other Clearances by Thermo Electron OY

    K Number Device Name
    K063705 LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL
    K063131 CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS
    K063838 LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH
    K063086 TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS
    K063209 HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL
    K063150 COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL
    K063647 CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH
    K061107 DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247