510(k) K082068 ยท JSS Kit, Identification, Enterobacteriaceae
E. COLI PNA FISH
| Applicant | Advandx, Inc., Woburn MA, US |
| Decision | Substantially Equivalent, Jun 25, 2009 |
| Received | Jul 22, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082068
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.