510(k) K063787 ยท NUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
INPLEX CF MOLECULAR TEST
| Applicant | Third Wave Technologies, Inc., Madison WI, US |
| Decision | Substantially Equivalent, Mar 13, 2008 |
| Received | Dec 21, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063787
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2016 | Hologic, Inc Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432. Terminated |
NUA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.