The following data is part of a premarket notification filed by Copan Wasp S.r.l. with the FDA for Colibri System.
| Device ID | K193138 |
| 510k Number | K193138 |
| Device Name: | Colibri System |
| Classification | Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry |
| Applicant | COPAN WASP S.r.l. Via F. Perotti 18 Brescia, IT 25125 |
| Contact | Catalano Giovanna |
| Correspondent | Bisson Enrico Studio D'ingegneria Enrico Bisson Via Marzia 9 Abano Terme, IT 35031 |
| Product Code | QQV |
| CFR Regulation Number | 866.3378 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-13 |
| Decision Date | 2021-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 58052870818435 | K193138 | 000 |
| 58052870818428 | K193138 | 000 |
| 58052870816202 | K193138 | 000 |
| 58050148218208 | K193138 | 000 |