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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name microbial colony image assessment system
De Novo Number DEN150059
Device Name APAS Compact with Urine Analysis Module
Requester
CLEVER CULTURE SYSTEMS AG
seestrasse 204a
baech,  CH 8806
Contact lusia guthrie
Regulation Number866.2190
Classification Product Code
PPU  
Date Received12/24/2015
Decision Date 10/06/2016
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
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