510(k) DEN150057
DEN150057 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5". The FDA issued a decision of De Novo granted on Dec 19, 2016. The device falls under product code PQO (Anti-Müllerian Hormone Test System), a Class II device regulated under 21 CFR 862.1092. Roche Diagnostics has 452 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo granted)
- Decision Date
- Dec 19, 2016
- Date Received
- Dec 9, 2015
- Clearance Type
- Direct
- 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
- 510(k)
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.