FDA 510(k) Application Details - K243575

Device Classification Name	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2   More FDA Info for this Device
510(K) Number	K243575
Device Name	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Applicant	Biokit, S.A. Av. Can Montcau 7 Lliτα dÆAmunt, Barcelona 08186 ES Other 510(k) Applications for this Company
Contact	Janna Puig 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	11/19/2024
Decision Date	02/12/2025
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