Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5
FDA 510(k) clearance DEN150057 · decided 2016-12-19
Clearance details
- K-number
- DEN150057
- Device name
- Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5
- Applicant
- Roche Diagnostics
- Decision
- Unknown
- Date received
- 2015-12-09
- Decision date
- 2016-12-19
- Days to decision
- 376 days
- Clearance type
- Direct
- Product code
- PQO
- Device class
- 2
- Regulation number
- 862.1092
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Indianapolis, IN, 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 |
|---|---|---|
| ADVIA Centaur® Anti-Müllerian Hormone (AMH) (K221801) | Siemens Healthcare Diagnostics, Inc. | 2023-06-02 |
| Access AMH (K223679) | Beckman Coulter, Inc. | 2023-02-03 |
| Elecsys AMH (K203757) | Roche Diagnostics | 2022-06-10 |
| Access AMH (K170524) | Beckman Coulter, Inc. | 2017-11-13 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S010) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S007) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S006) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs / Elecsys HBs II (P190034/S009) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs II (P190034/S008) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBe (P190005/S005) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007) | Roche Diagnostics | 2024-07-23 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005) | Roche Diagnostics | 2024-05-01 |