FDA 510(k) Application Details - K220911

Device Classification Name	Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus   More FDA Info for this Device
510(K) Number	K220911
Device Name	Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
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	866.3175   More FDA Info for this Regulation Number
Classification Product Code	LFZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/29/2022
Decision Date	10/12/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review