FDA 510(k) Application Details - K172613

Device Classification Name	More FDA Info for this Device
510(K) Number	K172613
Device Name	Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit
Applicant	The Binding Site Group Ltd. 8 Calthorpe Road, Edgbaston Birmingham B15 1QT GB Other 510(k) Applications for this Company
Contact	Andrea Thomas Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PCN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/31/2017
Decision Date	02/15/2018
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