FDA 510(k) Application Details - K190495

Device Classification Name	Transferrin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K190495
Device Name	Transferrin, Antigen, Antiserum, Control
Applicant	BioSystems S.A. Costa Brava, 30 Barcelona 08030 ES Other 510(k) Applications for this Company
Contact	Noelia Gil Other 510(k) Applications for this Contact
Regulation Number	866.5880   More FDA Info for this Regulation Number
Classification Product Code	DDG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/28/2019
Decision Date	03/16/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review