Thc DA4010
Thc DA4010 is a Class II device made by Randox Laboratories, Ltd., cleared under FDA 510(k) K092269 on 8 Apr 2011 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 05055273208030), 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 | Number05055273208030 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK092269 | Date8 Apr 2011 | StatusActive |
Official records
- AccessGUDID record 05055273208030
- FDA 510(k) database K092269
Across registries
- FDA 510(k) K092269 decided 8 Apr 2011 Active
- FDA GUDID UDI-DI 05055273208030 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K092269
- Listed FDA GUDID 05055273208030
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Thc
- Generic name
- Cannabinoid/cannabinoid metabolite IVD, reagent
- Model / Ref / Catalog
- DA4010
- Primary DI / UDI-DI
- 05055273208030
- 510(k) Number
- FDA product code
- LDJ
- GMDN term
- Cannabinoid/cannabinoid metabolite IVD, reagent
- Device class
- Class II
- Regulation number
- 862.3870
- GUDID distribution status
- In Commercial Distribution
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