510(k) K063127 ยท OAH Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis
ENTEROCOCCUS FAECALIS PNA FISH
| Applicant | Advandx, Inc., Canton MA, US |
| Decision | Substantially Equivalent, Dec 22, 2006 |
| Received | Oct 13, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063127
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.