FDA Product Code QQY: Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms
Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms Is An Automated System To Assess The Presence Or Absence Of Colony Growth On Solid Chromogenic Culture Media.
Leading manufacturers include Clever Culture Systems and Bd Kiestra B.V..
2
Total
2
Cleared
578d
Avg days
2021
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms Devices (Product Code QQY)
2 devices
Cleared
May 04, 2023
BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App
Bd Kiestra B.V.
Microbiology
580d
Cleared
Oct 28, 2021
APAS Independence with IC Chromogenic MRSA BD Analysis Module
Clever Culture Systems
Microbiology
576d
About Product Code QQY - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QQY since 2021, with 2 receiving FDA clearance (average review time: 578 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
QQY devices are reviewed by the Microbiology panel. Browse all Microbiology devices →