Architect 3L34-04
Architect 3L34-04 (03L3404) is an opiate/opiate metabolite IVD (FDA Class II; FDA product code DKB, Calibrators, Drug Mixture) made by Abbott Laboratories, cleared under FDA 510(k) K940935 on 6 Jul 1994 and listed in FDA GUDID since 6 Jun 2016 (UDI-DI 00380740005474), 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 | Number00380740005474 | Date6 Jun 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK940935 | Date6 Jul 1994 | StatusActive |
Official records
- AccessGUDID record 00380740005474
- FDA 510(k) database K940935
Across registries
- FDA 510(k) K940935 decided 6 Jul 1994 Active
- FDA GUDID UDI-DI 00380740005474 listed 6 Jun 2016 Listed
Timeline
- Cleared FDA 510(k) K940935
- Listed FDA GUDID 00380740005474
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Architect
- Generic name
- Opiate/opiate metabolite IVD, calibrator
- Model / Ref / Catalog
- 3L34-04, 03L3404
- Primary DI / UDI-DI
- 00380740005474
- 510(k) Number
- FDA product code
- DKB
- GMDN term
- Opiate/opiate metabolite IVD, calibrator
- Device class
- Class II
- Regulation number
- 862.3200
- GUDID distribution status
- In Commercial Distribution
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