510(k) K121991 ยท OAH Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis
ENTEROCOCCUS QUICKFISH BC
| Applicant | Advandx, Inc., Woburn MA, US |
| Decision | Substantially Equivalent, Jan 7, 2013 |
| Received | Jul 6, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121991
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.