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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 K193138
Device Name Colibri System
Applicant
Copan Wasp Srl
Via F. Perotti 18
Brescia,  IT 25125
Applicant Contact Catalano Giovanna
Correspondent
Studio D'Ingegneria Enrico Bisson
Via Marzia 9
Abano Terme,  IT 35031
Correspondent Contact Bisson Enrico
Classification Product Code
QQV  
Subsequent Product Code
QBN  
Date Received11/13/2019
Decision Date 12/27/2021
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
Predetermined Change
Control Plan Authorized		 No
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