FDA 510(k) Application Details - K991817

Device Classification Name	Saccharogenic, Amylase   More FDA Info for this Device
510(K) Number	K991817
Device Name	Saccharogenic, Amylase
Applicant	BAYER CORP. 511 BENEDICT AVE. TARRYTOWN, NY 10591-5097 US Other 510(k) Applications for this Company
Contact	GABRIEL J MURACA JR. Other 510(k) Applications for this Contact
Regulation Number	862.1070   More FDA Info for this Regulation Number
Classification Product Code	CIJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/27/1999
Decision Date	07/22/1999
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