510(k) K123418 ยท JSS Kit, Identification, Enterobacteriaceae
GRAM-NEGATIVE QUICKFISH BC
| Applicant | Advandx, Inc., Woburn MA, US |
| Decision | Substantially Equivalent, Jul 21, 2013 |
| Received | Nov 6, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123418
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 2, 2014 | AdvanDx, Inc. AdvanDx Gram-Negative QuickFISH BC.
In-Vitro Diagnostic for the identification of Enterobacteriacae
Catalog Number: QFGNRBC1-25
Gram-Negative QuickFISH BC provides rapid identification of Escherichi Terminated |
JSS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.