K220546 is an FDA 510(k) clearance for the Colibrí System. This device is classified as a System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (Class II - Special Controls, product code LON).
Submitted by Copan Wasp Srl (Brescia, IT). The FDA issued a Cleared decision on October 5, 2022, 222 days after receiving the submission on February 25, 2022.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1645.
| 510(k) Number | K220546 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 2022 |
| Decision Date | October 05, 2022 |
| Days to Decision | 222 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LON - System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1645 |