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

    LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL

    K Number: K063705 · Decision Oct 9, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    6
    Applicant Total
    9
    Review Days
    300

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    Basic Information

    Device Name
    LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL
    K Number
    K063705
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3560
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Thermo Electron OY
    Date Received
    December 13, 2006
    Decision Date
    October 9, 2007
    Product Code
    NDW
    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
    NDW Assay, Porphyrin, Spectrophotometry, Lithium

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    Other Clearances by Thermo Electron OY

    K Number Device Name
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    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