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

    PERKINELMER 226 SAMPLE COLLECTION DEVICES

    K Number: K121864 · Decision Mar 12, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    17
    Review Days
    259

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    Basic Information

    Device Name
    PERKINELMER 226 SAMPLE COLLECTION DEVICES
    K Number
    K121864
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Perkinelmer, Inc.
    Date Received
    June 26, 2012
    Decision Date
    March 12, 2013
    Product Code
    PJC
    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
    PJC Newborn Screening Specimen Collection Paper

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