The following data is part of a premarket notification filed by Copan Wasp S.r.l. with the FDA for Colibrí System.
| Device ID | K220546 |
| 510k Number | K220546 |
| Device Name: | Colibrí System |
| Classification | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Applicant | Copan WASP S.r.l. Via A. Grandi, 32 Brescia, IT 25125 |
| Contact | Giovanna Catalano |
| Correspondent | Chiara Congiu Copan WASP S.r.l. Via A. Grandi, 32 Brescia, IT 25125 |
| Product Code | LON |
| CFR Regulation Number | 866.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-25 |
| Decision Date | 2022-10-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18050148217968 | K220546 | 000 |
| 18050148212864 | K220546 | 000 |
| 08050148218005 | K220546 | 000 |