FDA 510(k) Application Details - K231601

Device Classification Name	Kappa, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K231601
Device Name	Kappa, Antigen, Antiserum, Control
Applicant	Sebia 1705 Corporate Drive Suite 400 Norcross, GA 30093 US Other 510(k) Applications for this Company
Contact	Karen Anderson Other 510(k) Applications for this Contact
Regulation Number	866.5550   More FDA Info for this Regulation Number
Classification Product Code	DFH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/2023
Decision Date	02/23/2024
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