FDA 510(k) Application Details - K002285

Device Classification Name	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes   More FDA Info for this Device
510(K) Number	K002285
Device Name	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Applicant	ELAN DIAGNOSTICS 231 NORTH PUENTE ST. BREA, CA 92821 US Other 510(k) Applications for this Company
Contact	WYNN STOCKING 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	07/26/2000
Decision Date	09/26/2000
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