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

    EPISCREEN

    K Number: K970357 · Decision Mar 10, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    8
    Applicant Total
    2
    Review Days
    39

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    Basic Information

    Device Name
    EPISCREEN
    K Number
    K970357
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Epitope, Inc.
    Date Received
    January 30, 1997
    Decision Date
    March 10, 1997
    Product Code
    PJD
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PJD Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device

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    Other Clearances by Epitope, Inc.

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