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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microbial Colony Image Assessment System
510(k) Number K251511
Device Name PhenoMATRIX
Applicant
Copan Wasp Srl
Via Achille Grandi, 32
Brescia,  IT 25125
Applicant Contact Chiara Congiu
Correspondent
Copan Wasp Srl
Via Achille Grandi, 32
Brescia,  IT 25125
Correspondent Contact Chiara Congiu
Regulation Number866.2190
Classification Product Code
PPU  
Subsequent Product Code
QQY  
Date Received05/16/2025
Decision Date 01/22/2026
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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