FDA 510(k) Application Details - K981897

Device Classification Name	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes   More FDA Info for this Device
510(K) Number	K981897
Device Name	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Applicant	ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 BRANCHBURG, NJ 08876-3771 US Other 510(k) Applications for this Company
Contact	RITA SMITH Other 510(k) Applications for this Contact
Regulation Number	862.1050   More FDA Info for this Regulation Number
Classification Product Code	CJE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/1998
Decision Date	08/26/1998
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