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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, nucleic acid amplification test, dna, carbapenem non-susceptible gram negative organism, colony
510(k) Number K190275
Device Name GenePOC Carba
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 Number866.1640
Classification Product Code
PMY  
Subsequent Product Code
OOI  
Date Received02/08/2019
Decision Date 05/10/2019
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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