Optilite IgG3 LK008.OPT.A
Optilite IgG3 LK008.OPT.A is a Class II device made by The Binding Site Group, cleared under FDA 510(k) K142735 on 21 Dec 2014 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 05051700017541), 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 | Number05051700017541 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k) | NumberK142735 | Date21 Dec 2014 | StatusActive |
Official records
- AccessGUDID record 05051700017541
- FDA 510(k) database K142735
Across registries
- FDA 510(k) K142735 decided 21 Dec 2014 Active
- FDA GUDID UDI-DI 05051700017541 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K142735
- Listed FDA GUDID 05051700017541
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Optilite IgG3
- Generic name
- Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry
- Model / reference
- LK008.OPT.A
- Primary DI / UDI-DI
- 05051700017541
- 510(k) Number
- FDA product code
- CFN
- GMDN term
- Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry
- Device class
- Class II
- Regulation number
- 866.5510
- GUDID distribution status
- In Commercial Distribution