510(k) DEN180004

picoAMH ELISA by Ansh Labs, LLC — Product Code QDH

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.