Phoenix Diagnostics, Inc. 16-215
Phoenix Diagnostics, Inc. 16-215 is a Class II device made by Phoenix Diagnostics, Inc., cleared under FDA 510(k) K013451 on 18 Dec 2001 and listed in FDA GUDID since 26 Jan 2018 (UDI-DI 00853366007271), 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 | Number00853366007271 | Date26 Jan 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK013451 | Date18 Dec 2001 | StatusActive |
Official records
- AccessGUDID record 00853366007271
- FDA 510(k) database K013451
Across registries
- FDA 510(k) K013451 decided 18 Dec 2001 Active
- FDA GUDID UDI-DI 00853366007271 listed 26 Jan 2018 Listed
Timeline
- Cleared FDA 510(k) K013451
- Listed FDA GUDID 00853366007271
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Phoenix Diagnostics, Inc.
- Generic name
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
- Model / reference
- 16-215
- Primary DI / UDI-DI
- 00853366007271
- 510(k) Number
- FDA product code
- JIX
- GMDN term
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
- Device class
- Class II
- Regulation number
- 862.1150
- GUDID distribution status
- In Commercial Distribution
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