510(k) K051435 ยท NUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800
| Applicant | Clinical Micro Sensors, Pasadena CA, US |
| Decision | Substantially Equivalent, Jan 19, 2006 |
| Received | Jun 1, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051435
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.