510(k) K092393 ยท JSS Kit, Identification, Enterobacteriaceae
EK/P. AERUGINOSA PNA FISH
| Applicant | Advandx, Inc., Woburn MA, US |
| Decision | Substantially Equivalent, Sep 1, 2009 |
| Received | Aug 5, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092393
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2010 | AdvanDx, Inc. AdvanDx EK/P. aeruginosa PNA FISH- Culture Identification Kit for identification of E. coli and/or K. pneumoniae and P. aeruginosa bacteremia (In-Vitro Diagnostic)
Catalog number: KT008
EK/P. aerugin Terminated |
JSS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.