FDA 510(k) Application Details - K221693

Device Classification Name	Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus   More FDA Info for this Device
510(K) Number	K221693
Device Name	Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus
Applicant	Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 US Other 510(k) Applications for this Company
Contact	Bin Sun Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MZO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/10/2022
Decision Date	01/04/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review