INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)
FDA 510(k) clearance K240315 · decided 2024-10-10
Clearance details
- K-number
- K240315
- Device name
- INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)
- Applicant
- Siemens Healthcare Diagnostics Products GmbH
- Decision
- Substantially Equivalent
- Date received
- 2024-02-02
- Decision date
- 2024-10-10
- Days to decision
- 251 days
- Clearance type
- Traditional
- Product code
- QLU
- Device class
- 2
- Regulation number
- 864.7295
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Marburg, DE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HemosIL Liquid Anti-Xa (K223187) | Instrumentation Laboratory CO | 2023-06-23 |
| HemosIL Liquid Anti-Xa (DEN190032) | Instrumentation Laboratory CO | 2020-09-17 |
Recalls involving this device
No recalls on record reference this clearance.