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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name microbial nucleic acid storage and stabilization device
510(k) Number K201849
Device Name eNAT molecular collection and preservation medium
Copan Italia S.p.A.
Via F. Perotti 10
Brescia,  IT 25125
Applicant Contact Elena Simeonato
Copan Italia S.p.A.
Via F. Perotti 10
Brescia,  IT 25125
Correspondent Contact Elena Simeonato
Regulation Number866.2950
Classification Product Code
Date Received07/06/2020
Decision Date 09/17/2020
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