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

    BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771

    K Number: K091292 · Decision Aug 25, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    5
    Review Days
    113

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771
    K Number
    K091292
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Becton, Dickinson and Company (BD)
    Date Received
    May 4, 2009
    Decision Date
    August 25, 2009
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JKA), ordered by most recent decision date.

    Female Culture Device; Male Culture Device; Transfer Device; Access Device

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Steripath® Flow™ Blood Collection System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all

    Other Clearances by Becton, Dickinson and Company (BD)

    K Number Device Name
    K253996 BD Surgiphor™ Antimicrobial Irrigation System (910110)
    K112586 CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM)
    K111366 BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM
    K110105 BD PEN NEEDLE