Phoenix Diagnostics, Inc.
Medical device manufacturer in Natick, MA.
21510(k) clearances
0PMA approvals
0recalls
Device types
- JJS Controls For Blood-Gases, (Assayed And… 5
- JJY Multi-Analyte Controls, All Kinds (Assayed) 5
- JIX Calibrator, Multi-Analyte Mixture 5
- JJR Electrolyte Controls (Assayed And Unassayed) 2
- CGZ Electrode, Ion-Specific, Chloride 2
- CHL Electrode Measurement, Blood-Gases (Pco2… 1
- JGS Electrode, Ion Specific, Sodium 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K023268 | Phoenix Ise Standard A,B and C for Roche/Avl SystemsJIX · Traditional | 11/15/2002SE |
| K020364 | Phoenix Ise Reagents for Beckman CX SystemsJGS · Traditional | 06/04/2002SE |
| K020148 | pHoenix ISE Reagents FOR Olympus AU Chemistry SystemsCGZ · Traditional | 02/04/2002SE |
| K020129 | Phoenix Eletrolyte Calibration Set for the Roche Cobas Ise ModuleJIX · Traditional | 02/01/2002SE |
| K013451 | Phoenoix Ise Reagents for Roche Hitachi, Models 700/900 SeriesCGZ · Traditional | 12/18/2001SE |
| K012987 | Phoenix Electrolyte Calibration Set for the Medical Easylyte Calcium AnalyzerJIX · Traditional | 11/07/2001SE |
| K012509 | Phoenix Electrolyte Calibration Set for the Dade/Behring/Behring Dimension Chemistry…JIX · Traditional | 10/09/2001SE |
| K960592 | Electrolyte StandardsJJR · Traditional | 05/13/1996SE |
| K945860 | Spectrum Co-Oximeter Linearity ControlJJS · Traditional | 01/17/1995SE |
| K920285 | Blood Gas/Ise Linearity ControlJJS · Traditional | 07/14/1992SE |
| K912718 | Enzyme Linearity ControlJJY · Traditional | 09/06/1991SE |
| K904075 | Clinical Chemistry ControlJJY · Traditional | 12/06/1990SE |
| K902675 | Multi Analyte Mixture, CalibratorsJIX · Traditional | 07/31/1990SE |
| K902616 | Bilirubin ControlJJY · Traditional | 07/19/1990SE |
| K902094 | Blood Gas/Ise ControlsJJY · Traditional | 07/19/1990SE |
| K902267 | Blood GASES/PC02, PO2 Analysis ProductsCHL · Traditional | 06/12/1990SE |
| K902095 | Blood Gas/Electrolyte/Co-Oximeter ControlsJJY · Traditional | 06/12/1990SE |
| K902266 | Electrolyte Controls (Assayed and Unassayed)JJR · Traditional | 06/06/1990SE |
| K901985 | Blood Gas ControlsJJS · Traditional | 06/06/1990SE |
| K901986 | Co-Oximeter ControlsJJS · Traditional | 05/31/1990SE |
| K901976 | Blood Gas/Co-Oximetry ControlJJS · Traditional | 05/31/1990SE |