FDA 510(k) Application Details - K103824

Device Classification Name	Method, Nephelometric, Immunoglobulins (G, A, M)   More FDA Info for this Device
510(K) Number	K103824
Device Name	Method, Nephelometric, Immunoglobulins (G, A, M)
Applicant	THE BINDING SITE PO BOX 11712 BIRMINGHAM B14 4ZB GB Other 510(k) Applications for this Company
Contact	SUZANNE HORNE 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	12/30/2010
Decision Date	02/27/2012
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