FDA 510(k) Application Details - K210633

Device Classification Name	Catalytic Methods, Amylase   More FDA Info for this Device
510(K) Number	K210633
Device Name	Catalytic Methods, Amylase
Applicant	Abbott Ireland Diagnostics Division Lisnarnuck Longford IE Other 510(k) Applications for this Company
Contact	Magdalena Suszko 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	03/03/2021
Decision Date	05/26/2022
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