FDA 510(k) Application Details - K181473

Device Classification Name	More FDA Info for this Device
510(K) Number	K181473
Device Name	DENV Detect NS1 ELISA
Applicant	InBios International, Inc. 307 Westlake Ave N, Suite 300 Seattle, WA 98109 US Other 510(k) Applications for this Company
Contact	Estela Raychaudhuri Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QCU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/04/2018
Decision Date	08/27/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review