FDA 510(k) Application Details - DEN200070

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN200070
Device Name	Simple 2 Test
Applicant	LetsGetChecked Inc. (formerly PrivaPath Diagnostics Inc.) Unit 3, Adelphi House, George's St Upper Dun Laoghaire A96 NY82 IE Other 510(k) Applications for this Company
Contact	Karen Walsh Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QYA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/16/2020
Decision Date	11/15/2023
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