FDA 510(k) Application Details - K040920

Device Classification Name	Catalytic Methods, Amylase   More FDA Info for this Device
510(K) Number	K040920
Device Name	Catalytic Methods, Amylase
Applicant	TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. ANAHEIM, CA 92807 US Other 510(k) Applications for this Company
Contact	JIAN VAECHES Other 510(k) Applications for this Contact
Regulation Number	862.1070   More FDA Info for this Regulation Number
Classification Product Code	JFJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/08/2004
Decision Date	05/10/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review