510(k) K092236 ยท JSS Kit, Identification, Enterobacteriaceae
E.COLI/P. AERUGINOSA PNA FISH
| Applicant | Advandx, Inc., Woburn MA, US |
| Decision | Substantially Equivalent, Dec 16, 2009 |
| Received | Jul 23, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092236
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 29, 2010 | AdvanDx, Inc. AdvanDx E. coli/P. aeruginosa PNA FISH Culture Identification Kit for the diagnosis of E. coli and/or P. aeruginosa bacteremia
Catalog Number: KT007 Terminated |
JSS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.