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

    INNOFLOUR TOPIRAMATE REAGENT SET

    K Number: K970510 · Decision May 12, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    11
    Review Days
    90

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    Basic Information

    Device Name
    INNOFLOUR TOPIRAMATE REAGENT SET
    K Number
    K970510
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3350
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Oxis Intl., Inc.
    Date Received
    February 11, 1997
    Decision Date
    May 12, 1997
    Product Code
    MSL
    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
    MSL System, Test, Topiramatee

    Other Clearances by Oxis Intl., Inc.

    K Number Device Name
    K972331 INNOFLUOR GENTAMICIN ASSAY SYSTEM
    K972330 INNOFLUOR PHENOBARBITAL ASSAY SYSTEM
    K970509 INNOFLOUR CALIBRATOR REAGENT SET
    K970517 INNOFLUOR TOPIRAMATE CONTROL SET
    K955568 INNOFLUOR QUINIDINE ASSAY SYSTEM
    K955570 INNOFLUOR AMIKACIN ASSAY SYSTEM
    K955569 INNOFLUOR GENTAMICIN ASSAY SYSTEM
    K955567 INNOFLUOR THEOPHYLLINE ASSAY SYSTEM
    K955562 INNOFLUOR PHENYTOIN ASSAY SYSTEM
    K950346 B-L RED(TM) DISCS
    Search all 11 clearances from Oxis Intl., Inc. →