FDA 510(k) Application Details - K183366

Device Classification Name	More FDA Info for this Device
510(K) Number	K183366
Device Name	GenePOC Strep A
Applicant	GenePOC Inc. 360 rue Franquet Quebec G1P 4N3 CA Other 510(k) Applications for this Company
Contact	Dany Leblanc Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/04/2018
Decision Date	03/06/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review