510(k) K061686 ยท NIJ System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
IDI-VANR ASSAY
| Applicant | Geneohm Sciences Canada, Inc., Baldwin MD, US |
| Decision | Substantially Equivalent, Aug 30, 2006 |
| Received | Jun 15, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061686
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.