510(k) K083074 ยท OAH Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis
AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT
| Applicant | Advandx, Inc., Woburn MA, US |
| Decision | Substantially Equivalent, Jul 24, 2009 |
| Received | Oct 15, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083074
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2010 | AdvanDx, Inc. E.faecalis/OE PNA FISH
Intended Use: E. faecalis/OE PNA FISH" (Cat. No. KT003) is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Enterococcus faecalis and s Terminated |
OAH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.