510(k) K221801
K221801 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "ADVIA Centaur® Anti-Müllerian Hormone (AMH)". The FDA issued a decision of Substantially Equivalent on June 2, 2023. The device falls under product code PQO (Anti-Müllerian Hormone Test System), a Class II device regulated under 21 CFR 862.1092. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 2, 2023
- Date Received
- June 21, 2022
- 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.