510(k) K162540 ยท KFF Assay, Heparin
INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls
| Applicant | Siemens Healthcare Diagnostics Prodcts GmbH, Marburg, DE |
| Decision | Substantially Equivalent, Aug 22, 2017 |
| Received | Sep 12, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162540
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.