FDA 510(k) Application Details - K191454

Device Classification Name	Catalytic Methods, Amylase   More FDA Info for this Device
510(K) Number	K191454
Device Name	Catalytic Methods, Amylase
Applicant	Siemens Healthcare Diagnostics Inc. 500 GBC Drive P.O. Box 6101, M/S 514 Newark, DE 19714 US Other 510(k) Applications for this Company
Contact	Catherine Daigle 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	05/31/2019
Decision Date	07/30/2019
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