FDA 510(k) Application Details - K200898

Device Classification Name	Bromcresol Green Dye-Binding, Albumin   More FDA Info for this Device
510(K) Number	K200898
Device Name	Bromcresol Green Dye-Binding, Albumin
Applicant	Medicon Hellas, S.A Melitona 5-7 Gerakas 15344 GR Other 510(k) Applications for this Company
Contact	Frank Matuszak Other 510(k) Applications for this Contact
Regulation Number	862.1035   More FDA Info for this Regulation Number
Classification Product Code	CIX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/03/2020
Decision Date	09/21/2021
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