510(k) K062028 ยท NUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01
| Applicant | Celera Diagnostics, Alameda CA, US |
| Decision | Substantially Equivalent, Sep 7, 2007 |
| Received | Jul 18, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062028
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.