FDA 510(k) Application Details - K193525

Device Classification Name	Iga, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K193525
Device Name	Iga, 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	866.5510   More FDA Info for this Regulation Number
Classification Product Code	CZP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/19/2019
Decision Date	06/26/2020
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