FDA 510(k) Application Details - K220924

Device Classification Name	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2   More FDA Info for this Device
510(K) Number	K220924
Device Name	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Applicant	Roche Diagnostics 9115 Hague Road PO Box 50416 Indianapolis, IN 46250 US Other 510(k) Applications for this Company
Contact	Cynthia Aker Other 510(k) Applications for this Contact
Regulation Number	866.3305   More FDA Info for this Regulation Number
Classification Product Code	MYF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/31/2022
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