510(k) K082612 ยท OAH Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis
GBS PNA FISH
| Applicant | Advandx, Inc., Woburn MA, US |
| Decision | Substantially Equivalent, May 5, 2009 |
| Received | Sep 9, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082612
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.