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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nucleic acid amplification assay system, group b streptococcus, direct specimen test
510(k) Number K170557
Device Name GenePOC GBS LB
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 Number866.3740
Classification Product Code
NJR  
Subsequent Product Code
OOI  
Date Received02/24/2017
Decision Date 05/25/2017
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
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