APAS Independence With IC Chromogenic MRSA BD Analysis Module; APAS Independence With IC Chromogenic MRSA TFS/S Analysis Module

Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms

Clever Culture Systems

The following data is part of a premarket notification filed by Clever Culture Systems with the FDA for Apas Independence With Ic Chromogenic Mrsa Bd Analysis Module; Apas Independence With Ic Chromogenic Mrsa Tfs/s Analysis Module.

Pre-market Notification Details

Device IDK200839
510k NumberK200839
Device Name:APAS Independence With IC Chromogenic MRSA BD Analysis Module; APAS Independence With IC Chromogenic MRSA TFS/S Analysis Module
ClassificationCulture Plate Imaging System For Qualitative Assessment Of Resistant Organisms
Applicant Clever Culture Systems Seestrasse 204a Bach,  CH Ch-8806
ContactJulie Winson
CorrespondentJulie Winson
Clever Culture Systems Seestrasse 204a Bach,  CH Ch-8806
Product CodeQQY  
CFR Regulation Number866.2190 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-31
Decision Date2021-10-28

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