Architect 6L97-20
Architect 6L97-20 (06L9720) is a Class II device made by Abbott Laboratories, cleared under FDA 510(k) K943414 on 9 Sep 1994 and listed in FDA GUDID since 6 Jun 2016 (UDI-DI 00380740011536), 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 | Number00380740011536 | Date6 Jun 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK943414 | Date9 Sep 1994 | StatusActive |
Official records
- AccessGUDID record 00380740011536
- FDA 510(k) database K943414
Across registries
- FDA 510(k) K943414 decided 9 Sep 1994 Active
- FDA GUDID UDI-DI 00380740011536 listed 6 Jun 2016 Listed
Timeline
- Cleared FDA 510(k) K943414
- Listed FDA GUDID 00380740011536
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Architect
- Generic name
- Propoxyphene IVD, kit, enzyme immunoassay (EIA)
- Model / Ref / Catalog
- 6L97-20, 06L9720
- Primary DI / UDI-DI
- 00380740011536
- 510(k) Number
- FDA product code
- JXN
- GMDN term
- Propoxyphene IVD, kit, enzyme immunoassay (EIA)
- Device class
- Class II
- Regulation number
- 862.3700
- GUDID distribution status
- In Commercial Distribution
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