FDA 510(k) Application Details - K183648

Device Classification Name	More FDA Info for this Device
510(K) Number	K183648
Device Name	APAS Independence with Urine Analysis Module
Applicant	Clever Culture Systems AG Seestrasse 204a Bach CH-8806 CH Other 510(k) Applications for this Company
Contact	Julie Winson 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	12/26/2018
Decision Date	05/15/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review