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

    Quantisal II Oral Fluid Collection Device

    K Number: K183048 · Decision Jul 29, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    8
    Applicant Total
    50
    Review Days
    269

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    Basic Information

    Device Name
    Quantisal II Oral Fluid Collection Device
    K Number
    K183048
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Immunalysis Corporation
    Date Received
    November 2, 2018
    Decision Date
    July 29, 2019
    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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