FDA 510(k) Application Details - K031947

Device Classification Name	Automated Urinalysis System   More FDA Info for this Device
510(K) Number	K031947
Device Name	Automated Urinalysis System
Applicant	BAYER HEALTHCARE, LLC 63 NORTH ST. MEDFIELD, MA 02052-1688 US Other 510(k) Applications for this Company
Contact	MARY E GRAY 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	06/24/2003
Decision Date	12/19/2003
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