FDA 510(k) Application Details - K182747

Device Classification Name	System, Test, Rheumatoid Factor   More FDA Info for this Device
510(K) Number	K182747
Device Name	System, Test, Rheumatoid Factor
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	866.5775   More FDA Info for this Regulation Number
Classification Product Code	DHR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2018
Decision Date	12/18/2018
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