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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name automated system for sample preparation and identification of microorganisms from cultured isolates by mass spectrometry
510(k) Number K223245
Device Name Colibrí
Copan WASP Srl
Via A. Grandi, 32
Brescia,  IT 25125
Applicant Contact Giovanna Catalano
Copan WASP Srl
Via A. Grandi, 32
Brescia,  IT 25125
Correspondent Contact Chiara Congiu
Regulation Number866.3378
Classification Product Code
Subsequent Product Codes
Date Received10/20/2022
Decision Date 03/20/2023
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