FDA 510(k) Application Details - K180559

Device Classification Name	More FDA Info for this Device
510(K) Number	K180559
Device Name	HSV 1 & 2 ELITe MGB Kit; ELITe InGenius
Applicant	ELITechGroup 21720 23rd Drive SE Suite 150 Bothell, WA 98021 US Other 510(k) Applications for this Company
Contact	Terry Trimingham Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/01/2018
Decision Date	10/29/2018
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