510(k) K090901 ยท NUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8
| Applicant | Osmetech Molecular Diagnostics, Pasadena CA, US |
| Decision | Substantially Equivalent, Jul 6, 2009 |
| Received | Apr 1, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090901
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 14, 2019 | Bard Peripheral Vascular Inc EQUISTREAM XK Long-Term Hemodialysis Catheter. REF/UDI:5913230/:(01)00801741013843; 16F Terminated |
MSD | None listed |
| Jun 14, 2019 | Bard Peripheral Vascular Inc EQUISTREAM XK Long-Term Hemodialysis Catheter. REF/UDI:5913190/(01)00801741013836; 16F Terminated |
MSD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.