Apo B LP3839
Apo B LP3839 is a Class I device made by Randox Laboratories, Ltd., cleared under FDA 510(k) K950383 on 15 Sep 1995 and listed in FDA GUDID since 26 Sep 2016 (UDI-DI 05055273204469), 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 | Number05055273204469 | Date26 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK950383 | Date15 Sep 1995 | StatusActive |
Official records
- AccessGUDID record 05055273204469
- FDA 510(k) database K950383
Across registries
- FDA 510(k) K950383 decided 15 Sep 1995 Active
- FDA GUDID UDI-DI 05055273204469 listed 26 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K950383
- Listed FDA GUDID 05055273204469
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Apo B
- Generic name
- Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry
- Model / Ref / Catalog
- LP3839
- Primary DI / UDI-DI
- 05055273204469
- 510(k) Number
- FDA product code
- JHN
- GMDN term
- Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry
- Device class
- Class I
- Regulation number
- 862.1475
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry.