Eddp Control 1 DA3123
Eddp Control 1 DA3123 is a 2-ethylidine-1 (FDA Class I; FDA product code DIF, Drug Mixture Control Materials) made by Randox Laboratories, Ltd., cleared under FDA 510(k) K092258 on 9 Nov 2010 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 05055273207910), 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 | Number05055273207910 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK092258 | Date9 Nov 2010 | StatusActive |
Official records
- AccessGUDID record 05055273207910
- FDA 510(k) database K092258
Across registries
- FDA 510(k) K092258 decided 9 Nov 2010 Active
- FDA GUDID UDI-DI 05055273207910 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K092258
- Listed FDA GUDID 05055273207910
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Eddp Control 1
- Generic name
- 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, control
- Model / Ref / Catalog
- DA3123
- Primary DI / UDI-DI
- 05055273207910
- 510(k) Number
- FDA product code
- DIF
- GMDN term
- 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, control
- Device class
- Class I
- Regulation number
- 862.3280
- GUDID distribution status
- In Commercial Distribution
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