Colibrí
FDA 510(k) clearance K223245 · decided 2023-03-20
Clearance details
- K-number
- K223245
- Device name
- Colibrí
- Applicant
- Copan Wasp Srl
- Decision
- Substantially Equivalent
- Date received
- 2022-10-20
- Decision date
- 2023-03-20
- Days to decision
- 151 days
- Clearance type
- Traditional
- Product code
- QQV
- Device class
- 2
- Regulation number
- 866.3378
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Brescia, IT
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Copan Wasp Srl
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BD Kiestra IdentifA (K222563) | Becton, Dickinson and Company | 2023-08-31 |
| Colibri System (K193138) | Copan Wasp Srl | 2021-12-27 |
| BD Kiestra IdentifA (K191964) | Becton, Dickinson and Company | 2021-11-03 |
Recalls involving this device
No recalls on record reference this clearance.