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

    TAP Blood Collection Device

    K Number: K161521 · Decision Feb 16, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    259

    Basic Information

    Device Name
    TAP Blood Collection Device
    K Number
    K161521
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Seventh Sense Biosystems, Inc.
    Date Received
    June 2, 2016
    Decision Date
    February 16, 2017
    Product Code
    PRJ
    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
    PRJ Capillary Blood Collection Device For Alternative Site Collection

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PRJ), ordered by most recent decision date.

    TAP Blood Collection Device

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
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    Other Clearances by Seventh Sense Biosystems, Inc.

    K Number Device Name
    K190225 TAP Blood Collection Device