FDA 510(k) Application Details - K110846

Device Classification Name	Urinalysis Controls (Assayed And Unassayed)   More FDA Info for this Device
510(K) Number	K110846
Device Name	Urinalysis Controls (Assayed And Unassayed)
Applicant	RANDOX LABORATORIES LIMITED 55 DIAMOND ROAD CRUMLIN CRUMLIN ANTRIM BT29 4QY GB Other 510(k) Applications for this Company
Contact	PAULINE ARMSTRONG Other 510(k) Applications for this Contact
Regulation Number	862.1660   More FDA Info for this Regulation Number
Classification Product Code	JJW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/28/2011
Decision Date	09/30/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review