Au B38858
Au B38858 is a Class II device made by Beckman Coulter, Inc., cleared under FDA 510(k) K142346 on 15 Oct 2014 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 15099590670108), 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 | Number15099590670108 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k) | NumberK142346 | Date15 Oct 2014 | StatusActive |
Official records
- AccessGUDID record 15099590670108
- FDA 510(k) database K142346
Across registries
- FDA 510(k) K142346 decided 15 Oct 2014 Active
- FDA GUDID UDI-DI 15099590670108 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K142346
- Listed FDA GUDID 15099590670108
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Au
- Generic name
- Microalbumin IVD, kit, nephelometry/turbidimetry
- Model / reference
- B38858
- Primary DI / UDI-DI
- 15099590670108
- 510(k) Number
- FDA product code
- DCF
- GMDN term
- Microalbumin IVD, kit, nephelometry/turbidimetry
- Device class
- Class II
- Regulation number
- 866.5040
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Microalbumin IVD, kit, nephelometry/turbidimetry.