FDA 510(k) Application Details - K954840

Device Classification Name	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes   More FDA Info for this Device
510(K) Number	K954840
Device Name	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Applicant	SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. ST. LOUIS, MO 63103 US Other 510(k) Applications for this Company
Contact	WILLIAM R GILBERT 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	10/20/1995
Decision Date	02/28/1996
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