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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
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