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

    QMS CARBAMAZEPINE ASSAY

    K Number: K940374 · Decision Jun 2, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    55
    Applicant Total
    28
    Review Days
    127

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    Basic Information

    Device Name
    QMS CARBAMAZEPINE ASSAY
    K Number
    K940374
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3645
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Seradyn, Inc.
    Date Received
    January 26, 1994
    Decision Date
    June 2, 1994
    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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    K060709 MULTIGENT GENTAMICIN
    K052826 QMS QUINIDINE. QMS QUINIDINE CALIBRATORS
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    K052815 QMS AMIKACIN REAGENTS
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