PicoAMH ELISA

Menopause Test System

Ansh Labs LLC

The following data is part of a De Novo classification by Ansh Labs Llc with the FDA for Picoamh Elisa.

Pre-market Notification Details

DeNovo IDDEN180004
Device Name:PicoAMH ELISA
ClassificationMenopause Test System
Applicant Ansh Labs LLC 445 Medical Center Blvd. Webster,  TX  77598
ContactAjay Kumar
Product CodeQDH  
CFR Regulation Number862.1093 [🔎]
DecisionGranted (DENG)
501(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardToxicology
Classification AdvisoryClinical Chemistry
TypeDirect
Date Received2018-01-22
Decision Date2018-10-24
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

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