K200839 is an FDA 510(k) clearance for the APAS Independence with IC Chromogenic MRSA BD Analysis Module. This device is classified as a Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms (Class II - Special Controls, product code QQY).
Submitted by Clever Culture Systems (Bach, CH). The FDA issued a Cleared decision on October 28, 2021, 576 days after receiving the submission on March 31, 2020.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2190. 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..
| 510(k) Number | K200839 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2020 |
| Decision Date | October 28, 2021 |
| Days to Decision | 576 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | QQY - Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.2190 |
| Definition | 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. |