FDA 510(k) Application Details - K193313

Device Classification Name	System, Test, Thyroid Autoantibody   More FDA Info for this Device
510(K) Number	K193313
Device Name	System, Test, Thyroid Autoantibody
Applicant	Roche Diagnostics 9115 Hague Road Indianapolis, IN 46256 US Other 510(k) Applications for this Company
Contact	Reanna Toney 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	11/29/2019
Decision Date	02/27/2020
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