Capi 3 Hemoglobin(E)
by Sebia
510(k) K180762
Capi 3 Hemoglobin(E) is a Class II device made by Sebia, cleared under FDA 510(k) K180762 on 14 Dec 2018, active as of 10 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK180762 | Date14 Dec 2018 | StatusActive |
Official records
- FDA 510(k) database K180762
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GKA
- Device class
- Class II
- Regulation
- 21 CFR Part 864.7415
- Advisory committee
- Hematology
- FDA decision
- SESE Substantially Equivalent
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