Accriva Diagnostics, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 3
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0880-2026 | Class II | Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron | November 5, 2025 |
| Z-0500-2026 | Class III | VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow P | October 21, 2025 |
| Z-0961-2025 | Class II | VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064 | December 2, 2024 |
| Z-0279-2025 | Class II | AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whol | September 27, 2024 |
| Z-1121-2022 | Class II | The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known t | March 30, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K223352 | Tenderfoot | March 2, 2023 |
| K202101 | GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron | December 29, 2021 |
| K193041 | Hemochron Signature Elite | November 22, 2019 |