FDA 510(k) Application Details - K203184

Device Classification Name	Immunoelectrophoretic, Immunoglobulins, (G, A, M)   More FDA Info for this Device
510(K) Number	K203184
Device Name	Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Applicant	Sebia 1705 Corporate Drive Suite 400 Norcross, GA 30096 US Other 510(k) Applications for this Company
Contact	Karen Anderson Other 510(k) Applications for this Contact
Regulation Number	866.5510   More FDA Info for this Regulation Number
Classification Product Code	CFF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/27/2020
Decision Date	11/12/2021
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