Architect 2K98-02
Architect 2K98-02 (02K9802) is a Class II device made by Abbott Laboratories, cleared under FDA 510(k) K030320 on 11 Apr 2003 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00380740003630), 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 | Number00380740003630 | Date9 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK030320 | Date11 Apr 2003 | StatusActive |
Official records
- AccessGUDID record 00380740003630
- FDA 510(k) database K030320
Across registries
- FDA 510(k) K030320 decided 11 Apr 2003 Active
- FDA GUDID UDI-DI 00380740003630 listed 9 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K030320
- Listed FDA GUDID 00380740003630
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Architect
- Generic name
- Microalbumin IVD, calibrator
- Model / Ref / Catalog
- 2K98-02, 02K9802
- Primary DI / UDI-DI
- 00380740003630
- 510(k) Number
- FDA product code
- JIS, JIQ, JJX
- GMDN term
- Microalbumin IVD, calibrator
- Device class
- Class II
- Regulation number
- 862.1150, 862.1645, 862.1660
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Microalbumin IVD, calibrator.