FDA 510(k) Application Details - K233605

Device Classification Name	Test, Antigen, Nuclear, Epstein-Barr Virus   More FDA Info for this Device
510(K) Number	K233605
Device Name	Test, Antigen, Nuclear, Epstein-Barr Virus
Applicant	Biokit S.A. Av. Can Montcau 7 Lliτα dÆAmunt 08186 ES Other 510(k) Applications for this Company
Contact	Dominique Monferrer Other 510(k) Applications for this Contact
Regulation Number	866.3235   More FDA Info for this Regulation Number
Classification Product Code	LLM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/09/2023
Decision Date	08/07/2024
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