FDA 510(k) Application Details - K203530

Device Classification Name	Bromcresol Purple Dye-Binding, Albumin   More FDA Info for this Device
510(K) Number	K203530
Device Name	Bromcresol Purple Dye-Binding, Albumin
Applicant	Abbott Ireland Diagnostics Division Lisnamuck Longford IE Other 510(k) Applications for this Company
Contact	Suzanne Cheang Other 510(k) Applications for this Contact
Regulation Number	862.1035   More FDA Info for this Regulation Number
Classification Product Code	CJW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/02/2020
Decision Date	03/18/2022
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