FDA 510(k) Application Details - K213987

Device Classification Name	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1   More FDA Info for this Device
510(K) Number	K213987
Device Name	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Applicant	Biokit, S.A. Av. Can Montcau, 7 Llica dÆAmunt 08186 ES Other 510(k) Applications for this Company
Contact	Angels Roma Other 510(k) Applications for this Contact
Regulation Number	866.3305   More FDA Info for this Regulation Number
Classification Product Code	MXJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/2021
Decision Date	09/20/2023
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