Panels › Hematology › Product code QLU · Class 2
Anti-Factor Xa Activity Test System, Apixaban
Regulation 864.7295
0510(k)s in 12 months (3 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in QLU
| Company | 510(k)s | Recalls |
|---|---|---|
| Instrumentation Laboratory CO | 2 | 1 |
| Siemens Healthcare Diagnostics Products GmbH | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 10, 2024 | K240315 | INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) Siemens Healthcare Diagnostics Products GmbH, DE | QLU |
| Jun 23, 2023 | K223187 | HemosIL Liquid Anti-Xa Instrumentation Laboratory CO | QLU |
| Sep 17, 2020 | DEN190032 | HemosIL Liquid Anti-Xa Instrumentation Laboratory CO | QLU |
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