FDA 510(k) Application Details - K221890

Device Classification Name	System,Test,Thyroglobulin   More FDA Info for this Device
510(K) Number	K221890
Device Name	System,Test,Thyroglobulin
Applicant	Roche Diagnostics 9115 Hague Road Indianapolis, IN 42650 US Other 510(k) Applications for this Company
Contact	Edie Eads Other 510(k) Applications for this Contact
Regulation Number	866.6010   More FDA Info for this Regulation Number
Classification Product Code	MSW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/29/2022
Decision Date	09/30/2023
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