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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
Applicant
Genepoc, Inc.
360 Rue Franquet
Quebec,  CA G1P 4N3
Applicant Contact Guy Sevigny
Correspondent
Genepoc, Inc.
360 Rue Franquet
Quebec,  CA G1P 4N3
Correspondent Contact Guy Sevigny
Regulation Number866.3130
Classification Product Code
OZN  
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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