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

    AKERS LABORATORIES INC. BLOOD CELL SEPARATOR

    K Number: K030815 · Decision Sep 17, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    3
    Review Days
    187

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    Basic Information

    Device Name
    AKERS LABORATORIES INC. BLOOD CELL SEPARATOR
    K Number
    K030815
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Akers Laboratories, Inc.
    Date Received
    March 14, 2003
    Decision Date
    September 17, 2003
    Product Code
    JKA
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

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    Other Clearances by Akers Laboratories, Inc.

    K Number Device Name
    K040293 HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY
    K031579 INSTAREAD LITHIUM SYSTEM