K213280 is an FDA 510(k) clearance for the BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App. 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 Bd Kiestra B.V. (Drachten, NL). The FDA issued a Cleared decision on May 4, 2023, 580 days after receiving the submission on October 1, 2021.
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 | K213280 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 2021 |
| Decision Date | May 04, 2023 |
| Days to Decision | 580 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. |