510(k) K123753 ยท NIJ System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
IMDX VANR FOR ABBOTT M2000
| Applicant | Intelligent Medical Devices, Inc., Beverly MA, US |
| Decision | Substantially Equivalent, Jul 17, 2013 |
| Received | Dec 6, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123753
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.