FDA 510(k) Application Details - K170558

Device Classification Name	Real Time Nucleic Acid Amplification System   More FDA Info for this Device
510(K) Number	K170558
Device Name	Real Time Nucleic Acid Amplification System
Applicant	GenePOC Inc. 360 rue Franquet Quebec G1P 4N3 CA Other 510(k) Applications for this Company
Contact	Guy Sevigny Other 510(k) Applications for this Contact
Regulation Number	862.2570   More FDA Info for this Regulation Number
Classification Product Code	OOI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/24/2017
Decision Date	05/25/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review