APAS Independence With Urine Analysis Module

Microbial Colony Image Assessment System

Clever Culture Systems AG

The following data is part of a premarket notification filed by Clever Culture Systems Ag with the FDA for Apas Independence With Urine Analysis Module.

Pre-market Notification Details

Device IDK183648
510k NumberK183648
Device Name:APAS Independence With Urine Analysis Module
ClassificationMicrobial Colony Image Assessment System
Applicant Clever Culture Systems AG Seestrasse 204a Bach,  CH Ch-8806
ContactJulie Winson
CorrespondentJulie Winson
Clever Culture Systems AG Seestrasse 204a Bach,  CH Ch-8806
Product CodePPU  
CFR Regulation Number866.2190 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-26
Decision Date2019-05-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
19354646000084 K183648 000
09354646000001 K183648 000

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