Phoenix Diagnostics, Inc. 21-107
Phoenix Diagnostics, Inc. 21-107 is a Class II device made by Phoenix Diagnostics, Inc., cleared under FDA 510(k) K020148 on 4 Feb 2002 and listed in FDA GUDID since 25 Jan 2018 (UDI-DI 00853366007073), active as of 22 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 | Number00853366007073 | Date25 Jan 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK020148 | Date4 Feb 2002 | StatusActive |
Official records
- AccessGUDID record 00853366007073
- FDA 510(k) database K020148
Across registries
- FDA 510(k) K020148 decided 4 Feb 2002 Active
- FDA GUDID UDI-DI 00853366007073 listed 25 Jan 2018 Listed
Timeline
- Cleared FDA 510(k) K020148
- Listed FDA GUDID 00853366007073
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Phoenix Diagnostics, Inc.
- Generic name
- Multiple electrolyte IVD, calibrator
- Model / reference
- 21-107
- Primary DI / UDI-DI
- 00853366007073
- 510(k) Number
- FDA product code
- JGS, CEM, CGZ
- GMDN term
- Multiple electrolyte IVD, calibrator
- Device class
- Class II
- Regulation number
- 862.1665, 862.1600, 862.1170
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Multiple electrolyte IVD, calibrator.