510(k) K203757
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 10, 2022
- Date Received
- December 23, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Anti-Müllerian Hormone Test System
- Device Class
- Class II
- Regulation Number
- 862.1092
- Review Panel
- TX
- Submission Type
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.