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

    SERADYN QMS TOPIRAMATE

    K Number: K070645 · Decision May 17, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    4
    Applicant Total
    28
    Review Days
    70

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    Basic Information

    Device Name
    SERADYN QMS TOPIRAMATE
    K Number
    K070645
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3350
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Seradyn, Inc.
    Date Received
    March 8, 2007
    Decision Date
    May 17, 2007
    Product Code
    NWM
    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
    NWM Immunoassay, Anti-Seizure Drug

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    Other Clearances by Seradyn, Inc.

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    K060709 MULTIGENT GENTAMICIN
    K052826 QMS QUINIDINE. QMS QUINIDINE CALIBRATORS
    K051211 QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS
    K052815 QMS AMIKACIN REAGENTS
    K050419 QMS VANCOMYCIN
    K042307 ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH)
    K033674 MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS
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