PQO — Anti-Müllerian Hormone Test System Class II
Classification Details
- Product Code
- PQO
- Device Class
- Class II
- Regulation Number
- 862.1092
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Chemistry
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K221801 | siemens healthcare diagnostics | ADVIA Centaur® Anti-Müllerian Hormone (AMH) | June 2, 2023 |
| K223679 | beckman coulter | Access AMH | February 3, 2023 |
| K203757 | roche diagnostics | Elecsys AMH | June 10, 2022 |
| K170524 | beckman coulter | Access AMH | November 13, 2017 |
| DEN150057 | roche diagnostics | Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5 | December 19, 2016 |