PQO
5 FDA 510(k) clearances · Product code
346 daysmedian time to decision
534 days90th percentile
5clearances measured
FDA profile
- Official device name
- Anti-Müllerian Hormone Test System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1092
- Medical specialty
- Clinical Chemistry
- FDA definition
- An Anti-Müllerian hormone test system is an in vitro diagnostic device intended to measure anti-Müllerian hormone in human serum and plasma. The test is intended to be used as an aid for assessing ovarian reserve in women.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| 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 |
| Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5 (DEN150057) | Roche Diagnostics | 2016-12-19 |
Track PQO automatically
Every clearance here is in the API, with alerts when new ones post.