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

    SALIVA SAMPLER

    K Number: K942435 · Decision Aug 21, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    8
    Applicant Total
    2
    Review Days
    458

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    Basic Information

    Device Name
    SALIVA SAMPLER
    K Number
    K942435
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Saliva Diagnostic Systems, Inc.
    Date Received
    May 20, 1994
    Decision Date
    August 21, 1995
    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 Saliva Diagnostic Systems, Inc.

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