510(k) K060627 ยท NUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
TAG-IT CYSTIC FIBROSIS KIT
| Applicant | Tm Bioscience Corporation, Toronto, Ontario, CA |
| Decision | Substantially Equivalent, Jun 7, 2006 |
| Received | Mar 9, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060627
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.