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510(k) K200839

Device
APAS Independence With IC Chromogenic MRSA BD Analysis Module; APAS Independence With IC Chromogenic MRSA TFS/S Analysis Module
Applicant
Clever Culture Systems
510(k) number
K200839
Product code
QQY  
Decision
Substantially Equivalent (SESE)
Decision date
2021-10-28
Date received
2020-03-31
Regulation
866.2190
Classification name
Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Julie Winson
Address
Seestrasse 204a Bach CH CH-8806 CH-8806

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QQY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K213280BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA AppBd Kiestra B.V.2023-05-04

Legacy Summary#

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FDA Review#

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