FDA 510(k) Application Details - K183007

Device Classification Name	Anti-Sm Antibody, Antigen And Control   More FDA Info for this Device
510(K) Number	K183007
Device Name	Anti-Sm Antibody, Antigen And Control
Applicant	Phadia AB Rapsgatan 7P Uppsala SE 754 50 SE Other 510(k) Applications for this Company
Contact	Carina Magnusson 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	10/31/2018
Decision Date	12/24/2018
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