510(k) K240315 ยท QLU Anti-Factor Xa Activity Test System, Apixaban
INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)
| Applicant | Siemens Healthcare Diagnostics Products GmbH, Marburg, DE |
| Decision | Substantially Equivalent, Oct 10, 2024 |
| Received | Feb 2, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240315
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.