Capillary's Hemoglobin(E) (Pn 2007)
by Sebia
510(k) K052291
Capillary's Hemoglobin(E) (Pn 2007) is a Class II device made by Sebia, cleared under FDA 510(k) K052291 on 27 Jun 2006, active as of 12 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 | NumberK052291 | Date27 Jun 2006 | StatusActive |
Official records
- FDA 510(k) database K052291
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- Withdrawn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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