Leader 5741863
Leader 5741863 is a Class II device made by Cardinal Health 110, Inc., cleared under FDA 510(k) K150022 on 7 Aug 2015 and listed in FDA GUDID since 14 Jan 2022 (UDI-DI 00096295141528), 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 | Number00096295141528 | Date14 Jan 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK150022 | Date7 Aug 2015 | StatusActive |
Official records
- AccessGUDID record 00096295141528
- FDA 510(k) database K150022
Across registries
- FDA 510(k) K150022 decided 7 Aug 2015 Active
- FDA GUDID UDI-DI 00096295141528 listed 14 Jan 2022 Listed
Timeline
- Cleared FDA 510(k) K150022
- Listed FDA GUDID 00096295141528
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Leader
- Generic name
- Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, rapid agglutination, clinical
- Model / Ref / Catalog
- 5741863
- Primary DI / UDI-DI
- 00096295141528
- FDA product code
- LCX
- GMDN term
- Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, rapid agglutination, clinical
- Device class
- Class II
- Regulation number
- 862.1155
- GUDID distribution status
- In Commercial Distribution
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