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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 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, 
Regulation Number862.1675
Classification Product Code
JKA  
Date Received11/09/2009
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
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