FDA 510(k) Application Details - K981653

Device Classification Name	Catalytic Methods, Amylase   More FDA Info for this Device
510(K) Number	K981653
Device Name	Catalytic Methods, Amylase
Applicant	ABBOTT LABORATORIES DEPT. 09VA LC-2 1920 HURD DRIVE IRVING, TX 75038 US Other 510(k) Applications for this Company
Contact	MARK LITTLEFIELD 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	05/11/1998
Decision Date	08/28/1998
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