510(k) K113371 ยท NXX Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus
STAPHYLOCOCCUS QUICKFISH BC
| Applicant | Advandx, Inc., Woburn MA, US |
| Decision | Substantially Equivalent, Apr 3, 2012 |
| Received | Nov 16, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113371
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 1, 2014 | Advandx Inc AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are components that are sold separately for the Staphylococcus QuickFISH BC test
Ca Terminated |
NXX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.