FDA 510(k) Application Details - K191562

Device Classification Name	Ferritin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K191562
Device Name	Ferritin, Antigen, Antiserum, Control
Applicant	HORIBA ABX SAS Parc Euromedecine, Rue Du Caducee BP7290 Montpellier Cedex 4 341184 FR Other 510(k) Applications for this Company
Contact	Caroline Ferrer Other 510(k) Applications for this Contact
Regulation Number	866.5340   More FDA Info for this Regulation Number
Classification Product Code	DBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/13/2019
Decision Date	03/06/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review