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

    EPISCREEN ORAL SPECIMEN COLLECTION DEVICE

    K Number: K973395 · Decision Feb 13, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    8
    Applicant Total
    2
    Review Days
    176

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    Basic Information

    Device Name
    EPISCREEN ORAL SPECIMEN COLLECTION DEVICE
    K Number
    K973395
    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
    August 21, 1997
    Decision Date
    February 13, 1998
    Product Code
    PJD
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    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.

    K Number Device Name
    K970357 EPISCREEN