The following data is part of a premarket notification filed by Life Technologies, Inc. with the FDA for Optmizer Cts T-cell Expansion Serum Free Medium.
| Device ID | K113566 |
| 510k Number | K113566 |
| Device Name: | OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM |
| Classification | Media, Culture, Ex Vivo, Tissue And Cell |
| Applicant | LIFE TECHNOLOGIES, INC. 3175 STALEY RD. Grand Island, NY 14072 |
| Contact | Kelli L Tanzella |
| Correspondent | Kelli L Tanzella LIFE TECHNOLOGIES, INC. 3175 STALEY RD. Grand Island, NY 14072 |
| Product Code | NDS |
| CFR Regulation Number | 876.5885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-02 |
| Decision Date | 2012-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10190302005173 | K113566 | 000 |
| 10190302005135 | K113566 | 000 |
| 10190302005142 | K113566 | 000 |
| 10190302014298 | K113566 | 000 |
| 10190302014281 | K113566 | 000 |
| 30190302014278 | K113566 | 000 |