FDA 510(k) Application Details - K151799

Device Classification Name	System, Test, Thyroid Autoantibody   More FDA Info for this Device
510(K) Number	K151799
Device Name	System, Test, Thyroid Autoantibody
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	866.5870   More FDA Info for this Regulation Number
Classification Product Code	JZO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/2015
Decision Date	03/25/2016
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