510(k) K113566

OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM by Life Technologies, Inc. — Product Code NDS

K113566 is an FDA 510(k) premarket notification submitted by Life Technologies, Inc. for the device "OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM". The FDA issued a decision of Substantially Equivalent on June 21, 2012. The device falls under product code NDS (Media, Culture, Ex Vivo, Tissue And Cell), a Class II device regulated under 21 CFR 876.5885. Life Technologies, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2012
Date Received
December 2, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Culture, Ex Vivo, Tissue And Cell
Device Class
Class II
Regulation Number
876.5885
Review Panel
GU
Submission Type