FDA 510(k) Application Details - DEN200040

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN200040
Device Name	OMNIgene GUT Dx
Applicant	DNA Genotek Inc. 3000 - 500 Palladium Drive Ottawa K2V 1C2 CA Other 510(k) Applications for this Company
Contact	Austin Udocor Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QPO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/15/2020
Decision Date	11/03/2021
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