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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
Applicant
Copan Italia Spa
Via F. Perotti 10
Brescia,  IT 25125
Applicant Contact Elena Simeonato
Correspondent
Copan Italia Spa
Via F. Perotti 10
Brescia,  IT 25125
Correspondent Contact Elena Simeonato
Classification Product Code
QBD  
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
Predetermined Change
Control Plan Authorized		 No
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