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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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