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

    VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE)

    K Number: K972404 · Decision Jul 22, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    12
    Applicant Total
    632
    Review Days
    26

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    Basic Information

    Device Name
    VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE)
    K Number
    K972404
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.2240
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    June 26, 1997
    Decision Date
    July 22, 1997
    Product Code
    KJA
    Advisory Committee
    Hematology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KJA Flask, Tissue Culture

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