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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name c. difficile toxin gene amplification assay
510(k) Number K172569
Device Name GenePOC CDiff
GenePOC Inc.
360 rue Franquet
Quebec,  CA G1P 4N3
Applicant Contact Guy Sevigny
GenePOC Inc.
360 rue Franquet
Quebec,  CA G1P 4N3
Correspondent Contact Guy Sevigny
Regulation Number866.3130
Classification Product Code
Date Received08/25/2017
Decision Date 11/22/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No