FDA 510(k) Application Details - K191635

Device Classification Name	Method, Nephelometric, Immunoglobulins (G, A, M)   More FDA Info for this Device
510(K) Number	K191635
Device Name	Method, Nephelometric, Immunoglobulins (G, A, M)
Applicant	The Binding Site Group Ltd. 8 Calthorpe Road Edgbaston B15 1QT GB Other 510(k) Applications for this Company
Contact	Natasha Verhaak Other 510(k) Applications for this Contact
Regulation Number	866.5510   More FDA Info for this Regulation Number
Classification Product Code	CFN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/19/2019
Decision Date	07/15/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review