FDA 510(k) Application Details - DEN160025

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN160025
Device Name	ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit
Applicant	ID-FISH TECHNOLOGY, INC 797 SAN ANTONIO ROAD PALO ALTO, CA 94303 US Other 510(k) Applications for this Company
Contact	JYOTSNA SHAH Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PYN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/27/2016
Decision Date	08/18/2017
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