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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 K183648
Device Name APAS Independence with Urine Analysis Module
Applicant
Clever Culture Systems AG
Seestrasse 204a
Bach,  CH CH-8806
Applicant Contact Julie Winson
Correspondent
Clever Culture Systems AG
Seestrasse 204a
Bach,  CH CH-8806
Correspondent Contact Julie Winson
Regulation Number866.2190
Classification Product Code
PPU  
Date Received12/26/2018
Decision Date 05/15/2019
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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