510(k) K113566 ยท NDS Media, Culture, Ex Vivo, Tissue And Cell
OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM
| Applicant | Life Technologies, Inc., Grand Island NY, US |
| Decision | Substantially Equivalent, Jun 21, 2012 |
| Received | Dec 2, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113566
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 25, 2018 | Life Technologies, Corp. Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numbers A1048503 and A1022103. Tissue and cell culture medium. Terminated |
NDS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.