510(k) K083294 ยท NUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST
| Applicant | Nanosphere, Inc., Northbrook IL, US |
| Decision | Substantially Equivalent, Jul 24, 2009 |
| Received | Nov 10, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083294
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.