FDA 510(k) Application Details - K161899

Device Classification Name	Ige, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K161899
Device Name	Ige, Antigen, Antiserum, Control
Applicant	PHADIA AB RAPSGATAN 7P UPPSALA 75137 SE Other 510(k) Applications for this Company
Contact	Ulf Karlberg Other 510(k) Applications for this Contact
Regulation Number	866.5510   More FDA Info for this Regulation Number
Classification Product Code	DGC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/11/2016
Decision Date	07/28/2016
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