Phoenix Diagnostics 19-007
Phoenix Diagnostics 19-007 is a Class II device made by Phoenix Diagnostics, Inc., cleared under FDA 510(k) K012987 on 7 Nov 2001 and listed in FDA GUDID since 12 Aug 2017 (UDI-DI 00853366007608), 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 | Number00853366007608 | Date12 Aug 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK012987 | Date7 Nov 2001 | StatusActive |
Official records
- AccessGUDID record 00853366007608
- FDA 510(k) database K012987
Across registries
- FDA 510(k) K012987 decided 7 Nov 2001 Active
- FDA GUDID UDI-DI 00853366007608 listed 12 Aug 2017 Listed
Timeline
- Cleared FDA 510(k) K012987
- Listed FDA GUDID 00853366007608
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Phoenix Diagnostics
- Generic name
- Multiple electrolyte IVD, calibrator
- Model / Ref / Catalog
- 19-007
- Primary DI / UDI-DI
- 00853366007608
- 510(k) Number
- FDA product code
- JIX
- GMDN term
- Multiple electrolyte IVD, calibrator
- Device class
- Class II
- Regulation number
- 862.1150
- GUDID distribution status
- In Commercial Distribution
- Size
- Total Volume — 1080 Milliliter
Similar devices in this category
Other devices filed under Multiple electrolyte IVD, calibrator.