510(k) K163336 ยท NUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR
| Applicant | Luminex Molecular Diagnostics, Inc., Toronto, CA |
| Decision | Unknown, Dec 15, 2016 |
| Received | Nov 28, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K163336
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.