Clearance Summary
OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM received FDA 510(k) clearance under submission number K113566, sponsored by Life Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2012-06-21.
- Submission: K113566
- Applicant / Sponsor: Life Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5885
- Decision date: 2012-06-21
Classification & Regulation
This clearance is catalogued under FDA product code NDS and 21 CFR 876.5885, within the Gastroenterology, Urology review panel as a Class II device.