FDA 510(k) Application Details - K162275

Device Classification Name	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes   More FDA Info for this Device
510(K) Number	K162275
Device Name	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Applicant	RANDOX LABORATORIES LIMITED 55 DIAMOND ROAD CRUMLIN, COUNTY ANTRIM BT29 4QY GB Other 510(k) Applications for this Company
Contact	Pauline Armstrong 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	08/12/2016
Decision Date	04/21/2017
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