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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms
510(k) Number K200839
Device Name APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module
Applicant
Clever Culture Systems
Seestrasse 204a
Bach,  CH CH-8806
Applicant Contact Julie Winson
Correspondent
Clever Culture Systems
Seestrasse 204a
Bach,  CH CH-8806
Correspondent Contact Julie Winson
Regulation Number866.2190
Classification Product Code
QQY  
Date Received03/31/2020
Decision Date 10/28/2021
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
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