FDA 510(k) Application Details - K182474

Device Classification Name	Catalytic Methods, Amylase   More FDA Info for this Device
510(K) Number	K182474
Device Name	Catalytic Methods, Amylase
Applicant	BioSystems S.A. Costa Brava, 30 Barcelona 08030 ES Other 510(k) Applications for this Company
Contact	Noelia Gil 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	09/10/2018
Decision Date	05/02/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review