BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    FPR CARBAMAZEPINE KIT

    K Number: K894519 · Decision Aug 28, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    55
    Applicant Total
    16
    Review Days
    39

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    Basic Information

    Device Name
    FPR CARBAMAZEPINE KIT
    K Number
    K894519
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3645
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Colony Laboratories, Inc.
    Date Received
    July 20, 1989
    Decision Date
    August 28, 1989
    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

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    Other Clearances by Colony Laboratories, Inc.

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    K894527 FPR PHENYTOIN KIT
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