510(k) DEN180004
DEN180004 is an FDA 510(k) premarket notification submitted by Ansh Labs, LLC for the device "picoAMH ELISA". The FDA issued a decision of De Novo Granted on October 24, 2018. The device falls under product code QDH (Menopause Test System), a Class II device regulated under 21 CFR 862.1093.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- October 24, 2018
- Date Received
- January 22, 2018
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Menopause Test System
- Device Class
- Class II
- Regulation Number
- 862.1093
- Review Panel
- CH
- Submission Type
A menopause test system is an in vitro diagnostic device intended to measure hormones or other analytes in human clinical specimens as an aid in the determination of menopausal status in women.