Oxycodone Enzyme Immunoassay 0241b
by Lin-Zhi International, Inc.
Oxycodone Enzyme Immunoassay 0241b is a Class II device made by Lin-Zhi International, Inc., cleared under FDA 510(k) K120763 on 1 Jun 2012 and listed in FDA GUDID since 5 Jul 2016 (UDI-DI B0760241B0), 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 | NumberB0760241B0 | Date5 Jul 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK120763 | Date1 Jun 2012 | StatusActive |
Official records
- FDA 510(k) database K120763
Across registries
- FDA 510(k) K120763 decided 1 Jun 2012 Active
- FDA GUDID UDI-DI B0760241B0 listed 5 Jul 2016 Listed
Timeline
- Cleared FDA 510(k) K120763
- Listed FDA GUDID B0760241B0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Oxycodone Enzyme Immunoassay
- Generic name
- Oxycodone IVD, kit, enzyme immunoassay (EIA)
- Model / Ref / Catalog
- 0241b
- Description
- Large Test Kit. Antibody/Substrate Reagent (R1): 1000 mL. Enzyme Conjugate Reagent (R2): 375 mL.
- Primary DI / UDI-DI
- B0760241B0
- 510(k) Number
- FDA product code
- DJG
- GMDN term
- Oxycodone IVD, kit, enzyme immunoassay (EIA)
- Device class
- Class II
- Regulation number
- 862.3650
- GUDID distribution status
- In Commercial Distribution