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

    SAFE NEEDLE DIRECT BLOOD TRANSFER DEVICE, MODEL TA-STV

    K Number: K974374 · Decision Jan 2, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    120
    Review Days
    43

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    Basic Information

    Device Name
    SAFE NEEDLE DIRECT BLOOD TRANSFER DEVICE, MODEL TA-STV
    K Number
    K974374
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ohmeda Medical
    Date Received
    November 20, 1997
    Decision Date
    January 2, 1998
    Product Code
    JKA
    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
    JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

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