FDA 510(k) Application Details - K011843

Device Classification Name	Catalytic Methods, Amylase   More FDA Info for this Device
510(K) Number	K011843
Device Name	Catalytic Methods, Amylase
Applicant	GENZYME CORP. 500 KENDALL STREET CAMBRIDGE, MA 02142-1562 US Other 510(k) Applications for this Company
Contact	BARBARA PIZZA 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	06/12/2001
Decision Date	08/10/2001
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