FDA 510(k) Application Details - K203597

Device Classification Name	Enzymatic Esterase--Oxidase, Cholesterol   More FDA Info for this Device
510(K) Number	K203597
Device Name	Enzymatic Esterase--Oxidase, Cholesterol
Applicant	Abbott Ireland Diagnostics Division Lisnamuck Longford IE Other 510(k) Applications for this Company
Contact	Tracy Schmidt Other 510(k) Applications for this Contact
Regulation Number	862.1175   More FDA Info for this Regulation Number
Classification Product Code	CHH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/09/2020
Decision Date	06/30/2022
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