FDA 510(k) Application Details - K182513

Device Classification Name	More FDA Info for this Device
510(K) Number	K182513
Device Name	FluChip-8G Influenza A+B Assay
Applicant	InDevR, Inc. 2100 Central Avenue, Suite 106 Boulder, CO 80301 US Other 510(k) Applications for this Company
Contact	Erica Dawson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OZE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/12/2018
Decision Date	04/22/2019
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