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

    INNOFLUOR PHENYTOIN ASSAY SYSTEM

    K Number: K955562 · Decision Jan 24, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    14
    Applicant Total
    11
    Review Days
    49

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    Basic Information

    Device Name
    INNOFLUOR PHENYTOIN ASSAY SYSTEM
    K Number
    K955562
    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
    December 6, 1995
    Decision Date
    January 24, 1996
    Product Code
    LGR
    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
    LGR Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)

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    Other Clearances by Oxis Intl., Inc.

    K Number Device Name
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    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
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