FDA 510(k) Application Details - K250549

Device Classification Name	Kappa, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K250549
Device Name	Kappa, Antigen, Antiserum, Control
Applicant	The Binding Site Group Ltd 8 Calthorpe Road Edgbaston Birmingham B15 1QT GB Other 510(k) Applications for this Company
Contact	Jolanta Wolff 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	02/25/2025
Decision Date	05/23/2025
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