FDA 510(k) Application Details - K033185

Device Classification Name	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes   More FDA Info for this Device
510(K) Number	K033185
Device Name	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	SHERRI L COENEN 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	10/01/2003
Decision Date	10/14/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review