HemosIL Liquid Anti-Xa
FDA 510(k) clearance DEN190032 · decided 2020-09-17
Clearance details
- K-number
- DEN190032
- Device name
- HemosIL Liquid Anti-Xa
- Applicant
- Instrumentation Laboratory CO
- Decision
- Unknown
- Date received
- 2019-06-25
- Decision date
- 2020-09-17
- Days to decision
- 450 days
- Clearance type
- Direct
- Product code
- QLU
- Device class
- 2
- Regulation number
- 864.7295
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Bedford, MA, US
- 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 |
|---|---|---|
| INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) (K240315) | Siemens Healthcare Diagnostics Products GmbH | 2024-10-10 |
| HemosIL Liquid Anti-Xa (K223187) | Instrumentation Laboratory CO | 2023-06-23 |
Recalls involving this device
No recalls on record reference this clearance.