Coleby G-427B
Coleby G-427B is a Class II device made by Bioland Technology Ltd., cleared under FDA 510(k) K191657 on 20 Mar 2020 and listed in FDA GUDID since 5 Nov 2021 (UDI-DI 06939184630236), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number06939184630236 | Date5 Nov 2021 | StatusListed |
| United States | FDA 510(k) | NumberK191657 | Date20 Mar 2020 | StatusActive |
Official records
- AccessGUDID record 06939184630236
- FDA 510(k) database K191657
Across registries
- FDA 510(k) K191657 decided 20 Mar 2020 Active
- FDA GUDID UDI-DI 06939184630236 listed 5 Nov 2021 Listed
Timeline
- Cleared FDA 510(k) K191657
- Listed FDA GUDID 06939184630236
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Coleby
- Generic name
- Glucose monitoring system IVD, home-use
- Model / reference
- G-427B
- Primary DI / UDI-DI
- 06939184630236
- 510(k) Number
- FDA product code
- NBW
- GMDN term
- Glucose monitoring system IVD, home-use
- Device class
- Class II
- Regulation number
- 862.1345
- GUDID distribution status
- In Commercial Distribution
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