FDA 510(k) Application Details - K133404

Device Classification Name	Ige, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K133404
Device Name	Ige, Antigen, Antiserum, Control
Applicant	PHADIA AB 4169 COMMERCIAL AVE. PORTAGE, MI 49002 US Other 510(k) Applications for this Company
Contact	MARTIN R MANN 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	11/06/2013
Decision Date	02/24/2014
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