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

    ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT

    K Number: K073720 · Decision Jul 17, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    3
    Review Days
    199

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    Basic Information

    Device Name
    ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT
    K Number
    K073720
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3360
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Osmetech Molecular Diagnostics
    Date Received
    December 31, 2007
    Decision Date
    July 17, 2008
    Product Code
    ODW
    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
    ODW Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System

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    Other Clearances by Osmetech Molecular Diagnostics

    K Number Device Name
    K093974 ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING
    K090901 ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8