FDA 510(k) Application Details - K132631

Device Classification Name	Anti-Sm Antibody, Antigen And Control   More FDA Info for this Device
510(K) Number	K132631
Device Name	Anti-Sm Antibody, Antigen And Control
Applicant	PHADIA US INC. 4169 COMMERCIAL AVE. PORTAGE, MI 49002 US Other 510(k) Applications for this Company
Contact	MARTIN ROBERT MANN Other 510(k) Applications for this Contact
Regulation Number	866.5100   More FDA Info for this Regulation Number
Classification Product Code	LKP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/22/2013
Decision Date	08/29/2014
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