FDA 510(k) Application Details - DEN150059

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN150059
Device Name	APAS Compact with Urine Analysis Module
Applicant	CLEVER CULTURE SYSTEMS AG SEESTRASSE 204A BAECH 8806 CH Other 510(k) Applications for this Company
Contact	Lusia Guthrie Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PPU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/24/2015
Decision Date	10/06/2016
Decision	DENG -
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review