Architect 7K00-40
Architect 7K00-40 (07K0040) is a Class II device made by Abbott Laboratories, cleared under FDA 510(k) K050487 on 26 Apr 2005 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00380740054267), 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 | Number00380740054267 | Date9 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK050487 | Date26 Apr 2005 | StatusActive |
Official records
- AccessGUDID record 00380740054267
- FDA 510(k) database K050487
Across registries
- FDA 510(k) K050487 decided 26 Apr 2005 Active
- FDA GUDID UDI-DI 00380740054267 listed 9 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K050487
- Listed FDA GUDID 00380740054267
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Architect
- Generic name
- Lipoprotein A IVD, kit, nephelometry/turbidimetry
- Model / Ref / Catalog
- 7K00-40, 07K0040
- Primary DI / UDI-DI
- 00380740054267
- 510(k) Number
- FDA product code
- DFC, JJX, JIS
- GMDN term
- Lipoprotein A IVD, kit, nephelometry/turbidimetry
- Device class
- Class II
- Regulation number
- 866.5600, 862.1660, 862.1150
- GUDID distribution status
- In Commercial Distribution