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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
510(k) Number K220546
Device Name Colibrí System
Applicant
Copan WASP S.r.l.
Via A. Grandi, 32
Brescia,  IT 25125
Applicant Contact Giovanna Catalano
Correspondent
Copan WASP S.r.l.
Via A. Grandi, 32
Brescia,  IT 25125
Correspondent Contact Chiara Congiu
Regulation Number866.1645
Classification Product Code
LON  
Date Received02/25/2022
Decision Date 10/05/2022
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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