FDA 510(k) Application Details - DEN190031

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN190031
Device Name	NP Screen
Applicant	Advance Sentry Corporation 7155 Woodbine Avenue, Suite 202 Markham L3R 1A3 CA Other 510(k) Applications for this Company
Contact	Leo Chui Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OJY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/24/2019
Decision Date	05/11/2020
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