510(k) K103302
K103302 is an FDA 510(k) premarket notification submitted by Life Technologies Corporation for the device "STEMPRO MSC SFM". The FDA issued a decision of Substantially Equivalent on February 18, 2011. 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 Corporation has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 18, 2011
- Date Received
- November 9, 2010
- 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