FDA 510(k) Application Details - K061970

Device Classification Name	Radioimmunoassay, Immunoglobulins (D, E)   More FDA Info for this Device
510(K) Number	K061970
Device Name	Radioimmunoassay, Immunoglobulins (D, E)
Applicant	Roche Diagnostics 9115 HAGUE ROAD INDIANAPOLIS, IN 46250-0416 US Other 510(k) Applications for this Company
Contact	KAY A TAYLOR Other 510(k) Applications for this Contact
Regulation Number	866.5510   More FDA Info for this Regulation Number
Classification Product Code	JHR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/12/2006
Decision Date	08/31/2006
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