FDA 510(k) Application Details - DEN180069

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN180069
Device Name	ZIKV Detect 2.0 IgM Capture 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	QFO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/26/2018
Decision Date	05/23/2019
Decision	DENG -
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review