Miris Human Milk Analyzer

Breast Milk Macronutrients Test System

The following data is part of a De Novo classification by Miris Ab with the FDA for Miris Human Milk Analyzer.

DeNovo ID	DEN180007
Device Name:	Miris Human Milk Analyzer
Classification	Breast Milk Macronutrients Test System
Applicant	Miris AB kungsgatan 115 Uppsala, SE 753 18
Contact	Elin Hallen
Product Code	QEI
CFR Regulation Number	862.1493 [🔎]
Decision	Granted (DENG)
510(k) Premarket Notification	Device 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 Board	Clinical Chemistry
Classification Advisory	Clinical Chemistry
Type	Direct
Date Received	2018-02-12
Decision Date	2018-12-21
Reclassification Order:	Reclassification Order