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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
Predetermined Change
Control Plan Authorized		 No
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