Optilite IgD Kit LK013.OPT.A
Optilite IgD Kit LK013.OPT.A is a Class II device made by The Binding Site Group, cleared under FDA 510(k) K092450 on 28 Dec 2009 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 05051700017572), 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 | Number05051700017572 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK092450 | Date28 Dec 2009 | StatusActive |
Official records
- AccessGUDID record 05051700017572
- FDA 510(k) database K092450
Across registries
- FDA 510(k) K092450 decided 28 Dec 2009 Active
- FDA GUDID UDI-DI 05051700017572 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K092450
- Listed FDA GUDID 05051700017572
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Optilite IgD Kit
- Generic name
- Total immunoglobulin D (IgD total) IVD, kit, nephelometry/turbidimetry
- Model / reference
- LK013.OPT.A
- Primary DI / UDI-DI
- 05051700017572
- 510(k) Number
- FDA product code
- CZJ
- GMDN term
- Total immunoglobulin D (IgD total) IVD, kit, nephelometry/turbidimetry
- Device class
- Class II
- Regulation number
- 866.5510
- GUDID distribution status
- In Commercial Distribution
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