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 Number | 862.1675
|
Classification Product Code |
|
Date Received | 06/24/2005 |
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
|
|
|