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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name tubes, vials, systems, serum separators, blood collection
510(k) Number BK050036
Tradenames BD Vacutainer Plus K2EDTA Tubes, BD Vacutainer Plus Serum Tubes, BD Vacutainer SST Glass Tubes, BD Vacutainer SST II Advance Tubes, BD Vacutainer SST Plus Tubes
Device Name Tubes, Vials, Systems, Serum Separators, Blood Collection
Original Applicant
Becton, Dickinson & Company
1 becton drive
franklin lakes,  NJ  07417 1885
Regulation Number862.1675
Classification Product Code
JKA  
Date Received06/24/2005
Decision Date 02/24/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product Yes
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