Device Classification Name |
tubes, vials, systems, serum separators, blood collection
|
510(k) Number |
BK090069 |
Tradenames |
Endoret Kit,
Secondary Product Code: FMI, GKT
|
Device Name |
Tubes, Vials, Systems, Serum Separators, Blood Collection |
Original Applicant |
Biotechnology Institute, SL. |
c/leonardo da vinci 14b, 1b. |
01510 minano (alava) |
alava,
01510,
SPAIN
|
|
Regulation Number | 862.1675
|
Classification Product Code |
|
Date Received | 11/09/2009 |
Decision Date | 02/01/2010 |
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 |
Yes
|
In Vitro Product |
Yes
|
|
|