510(k) K113566
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