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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
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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
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