FDA 510(k) Application Details - K121456

Device Classification Name	Automated Urinalysis System   More FDA Info for this Device
510(K) Number	K121456
Device Name	Automated Urinalysis System
Applicant	ARKRAY, INC. 5182 West 76th Street Edina, MN 55439 US Other 510(k) Applications for this Company
Contact	ADAM ETTL 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	05/16/2012
Decision Date	02/01/2013
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