FDA 510(k) Application Details - K210452

Device Classification Name	Alkaline Picrate, Colorimetry, Creatinine   More FDA Info for this Device
510(K) Number	K210452
Device Name	Alkaline Picrate, Colorimetry, Creatinine
Applicant	Abbott Ireland Diagnostics Division Lisnamuck Longford IE Other 510(k) Applications for this Company
Contact	Magdalena Suszko Other 510(k) Applications for this Contact
Regulation Number	862.1225   More FDA Info for this Regulation Number
Classification Product Code	CGX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/16/2021
Decision Date	03/22/2022
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