FDA Product Code
FDA Product Code QLU — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7295
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K240315 | INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) | Siemens Healthcare Diagnostics Products GmbH | 2024-10-10 | Traditional | PDF ↗ |
| K223187 | HemosIL Liquid Anti-Xa | Instrumentation Laboratory CO | 2023-06-23 | Traditional | PDF ↗ |
| DEN190032 | HemosIL Liquid Anti-Xa | Instrumentation Laboratory CO | 2020-09-17 | Direct | — |
Product code QLU · Class II · Hematology. Data: openFDA.