510(k) K060543 ยท NUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800
| Applicant | Clinical Micro Sensors, Inc., Pasadena CA, US |
| Decision | Substantially Equivalent, Mar 28, 2006 |
| Received | Mar 1, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060543
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.