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

    CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS

    K Number: K063131 · Decision Oct 5, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    55
    Applicant Total
    9
    Review Days
    357

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS
    K Number
    K063131
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3645
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Thermo Electron OY
    Date Received
    October 13, 2006
    Decision Date
    October 5, 2007
    Product Code
    KLT
    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
    KLT Enzyme Immunoassay, Carbamazepine

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KLT), ordered by most recent decision date.

    Carbamazepine Gen 4

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ABBOTT CARBAMAZEPINE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ADVIA IMS CARBAMAZEPINE METHOD

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ONLINE TDM CARBAMAZEPINE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    RANDOX CARBAMAZEPINE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology
    View all

    Other Clearances by Thermo Electron OY

    K Number Device Name
    K063145 PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS
    K063705 LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL
    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