K113566 is an FDA 510(k) clearance for the OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM, a Media, Culture, Ex Vivo, Tissue And Cell (Class II — Special Controls, product code NDS), submitted by Life Technologies, Inc. (Grand Island, US). The FDA issued a Cleared decision on June 21, 2012, 202 days after receiving the submission on December 2, 2011. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5885.
| 510(k) Number | K113566 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 02, 2011 |
| Decision Date | June 21, 2012 |
| Days to Decision | 202 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | NDS — Media, Culture, Ex Vivo, Tissue And Cell |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5885 |