Lp(a) Ultra 11504D
Lp(a) Ultra 11504D is a Class II device made by Sentinel Ch. Srl, cleared under FDA 510(k) K211058 on 22 Dec 2022 and listed in FDA GUDID since 15 Mar 2024 (UDI-DI 08058056680211), active as of 23 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 | Number08058056680211 | Date15 Mar 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK211058 | Date22 Dec 2022 | StatusActive |
Official records
- AccessGUDID record 08058056680211
- FDA 510(k) database K211058
Across registries
- FDA 510(k) K211058 decided 22 Dec 2022 Active
- FDA GUDID UDI-DI 08058056680211 listed 15 Mar 2024 Listed
Timeline
- Cleared FDA 510(k) K211058
- Listed FDA GUDID 08058056680211
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Lp(a) Ultra
- Generic name
- Lipoprotein A IVD, reagent
- Model / Ref / Catalog
- 11504D
- Primary DI / UDI-DI
- 08058056680211
- 510(k) Number
- FDA product code
- DFC
- GMDN term
- Lipoprotein A IVD, reagent
- Device class
- Class II
- Regulation number
- 866.5600
- GUDID distribution status
- In Commercial Distribution
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