510(k) K143470 ยท GIS Test, Fibrinogen
Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set
| Applicant | Diazyme Laboratories, Poway CA, US |
| Decision | Substantially Equivalent, Jan 31, 2016 |
| Received | Dec 5, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143470
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.