FDA 510(k) Application Details - K212769

Device Classification Name	Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus   More FDA Info for this Device
510(K) Number	K212769
Device Name	Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus
Applicant	Dynex Technologies Inc. 14340 Sullyfield Circle Chantilly, VA 20151 US Other 510(k) Applications for this Company
Contact	Jeff Fisher Other 510(k) Applications for this Contact
Regulation Number	866.3510   More FDA Info for this Regulation Number
Classification Product Code	OPL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/31/2021
Decision Date	09/29/2023
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