BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SPOTCHECK BLOOD SPOT CONTROL, ASSAYED

    K Number: K090940 · Decision Dec 14, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    96
    Applicant Total
    9
    Review Days
    255

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    Basic Information

    Device Name
    SPOTCHECK BLOOD SPOT CONTROL, ASSAYED
    K Number
    K090940
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Astoria-Pacific, Inc.
    Date Received
    April 3, 2009
    Decision Date
    December 14, 2009
    Product Code
    JJT
    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
    JJT Enzyme Controls (Assayed And Unassayed)

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