510(k) K083846 ยท NUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267
| Applicant | Luminex Molecular Diagnostics, Inc., Toronto, Ontario, CA |
| Decision | Substantially Equivalent, Sep 1, 2009 |
| Received | Dec 24, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083846
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.