Phoenix Diagnostics 3-221
Phoenix Diagnostics 3-221 is a Class II device made by Phoenix Diagnostics, Inc., cleared under FDA 510(k) K902267 on 12 Jun 1990 and listed in FDA GUDID since 12 Aug 2017 (UDI-DI 00852676007049), 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 | Number00852676007049 | Date12 Aug 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK902267 | Date12 Jun 1990 | StatusActive |
Official records
- AccessGUDID record 00852676007049
- FDA 510(k) database K902267
Across registries
- FDA 510(k) K902267 decided 12 Jun 1990 Active
- FDA GUDID UDI-DI 00852676007049 listed 12 Aug 2017 Listed
Timeline
- Cleared FDA 510(k) K902267
- Listed FDA GUDID 00852676007049
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Phoenix Diagnostics
- Generic name
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator
- Model / reference
- 3-221
- Primary DI / UDI-DI
- 00852676007049
- 510(k) Number
- FDA product code
- JIX
- GMDN term
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator
- Device class
- Class II
- Regulation number
- 862.1150
- GUDID distribution status
- In Commercial Distribution
- Size
- Total Volume — 460 Milliliter
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