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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name groups a, c and g beta-hemolytic streptococcus nucleic acid amplification system
510(k) Number K183366
Device Name GenePOC Strep A
Applicant
GenePOC Inc.
360 rue Franquet
Quebec,  CA G1P 4N3
Applicant Contact Dany Leblanc
Correspondent
GenePOC Inc.
360 rue Franquet
Quebec,  CA G1P 4N3
Correspondent Contact Dany Leblanc
Regulation Number866.2680
Classification Product Code
PGX  
Subsequent Product Code
OOI  
Date Received12/04/2018
Decision Date 03/06/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT03422341
Reviewed by Third Party No
Combination Product No
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