510(k) K140436 ยท OSX Galectin-3 In Vitro Diagnostic Assay
ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS
| Applicant | Fujirebio Diagnostics,Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Dec 23, 2014 |
| Received | Feb 21, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140436
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.