FDA 510(k) Application Details - K190275

Device Classification Name	More FDA Info for this Device
510(K) Number	K190275
Device Name	GenePOC Carba
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	PMY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/08/2019
Decision Date	05/10/2019
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