FDA 510(k) Application Details - K140717

Device Classification Name	Automated Urinalysis System   More FDA Info for this Device
510(K) Number	K140717
Device Name	Automated Urinalysis System
Applicant	SIEMENS HEALTHCARE DIAGNOSTICS 2 EDGEWATER DRIVE NORWOOD, MA 02062 US Other 510(k) Applications for this Company
Contact	Susan Tibedo Other 510(k) Applications for this Contact
Regulation Number	862.2900   More FDA Info for this Regulation Number
Classification Product Code	KQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/20/2014
Decision Date	11/17/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review