FDA 510(k) Application Details - DEN180007

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN180007
Device Name	Miris Human Milk Analyzer
Applicant	Miris AB Kungsgatan 115 UPPSALA 753 18 SE Other 510(k) Applications for this Company
Contact	Elin Hallen Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/12/2018
Decision Date	12/21/2018
Decision	DENG -
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review