Data / Medical devices / United States / Phoenix Diagnostics, Inc.
Phoenix Diagnostics, Inc.: FDA-registered device maker in Natick, MA, United States, 7 510(k) clearances
Phoenix Diagnostics, Inc. is registered with the FDA (registration 1222035) in Natick, MA, United States. It lists 9 device types. The FDA files 7 510(k) clearances under its listings, the newest dated November 15, 2002. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1222035
- Address
- 8 Tech Circle, Natick, MA, United States, 01760
- Owner or operator
- PHOENIX DIAGNOSTICS, INC. (1222035)
- Roles
- Manufacturer
- First device listed
- November 8, 2007
- Registered through
- 2026
- Brand names listed
- Blood Gas / ISE Linearity Control, Blood Gases/ PCO2, PO2 Analysis Products, Chemistry Control, Enzyme Linearity Control, Phoenix Calibrators for ISE Module, Phoenix ISE Reagents for Olympus AU Chemistry Systems, Phoenix ISE Reagents for Roche/Hitachi 700/900 series, Phoenix ISE Standards for Roche AVL 982,983,984,985,986,987,988,9110/9140,9120/9130,9180/9181
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calibrator, Multi-Analyte Mixture | JIX | 2 | Manufacturer | accessdata.fda.gov |
| Controls For Blood-Gases, (Assayed And Unassayed) | JJS | 1 | Manufacturer | accessdata.fda.gov |
| Detergent | JCB | 1 | Manufacturer | accessdata.fda.gov |
| Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | CHL | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Ion Specific, Potassium | CEM | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Ion Specific, Sodium | JGS | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Ion-Specific, Chloride | CGZ | 2 | Manufacturer | accessdata.fda.gov |
| General Purpose Reagent | PPM | 1 | Manufacturer | accessdata.fda.gov |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 15, 2002 | K023268 | PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS | JIX | Substantially Equivalent | Phoenix Diagnostics, Inc. | accessdata.fda.gov |
| February 4, 2002 | K020148 | pHoenix ISE Reagents FOR Olympus AU Chemistry Systems | CGZ | Substantially Equivalent | Phoenix Diagnostics, Inc. | accessdata.fda.gov |
| December 18, 2001 | K013451 | PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES | CGZ | Substantially Equivalent | Phoenix Diagnostics, Inc. | accessdata.fda.gov |
| July 14, 1992 | K920285 | BLOOD GAS/ISE LINEARITY CONTROL | JJS | Substantially Equivalent | Phoenix Diagnostics, Inc. | accessdata.fda.gov |
| September 6, 1991 | K912718 | ENZYME LINEARITY CONTROL | JJY | Substantially Equivalent | Phoenix Diagnostics, Inc. | accessdata.fda.gov |
| December 6, 1990 | K904075 | CLINICAL CHEMISTRY CONTROL | JJY | Substantially Equivalent | Phoenix Diagnostics, Inc. | accessdata.fda.gov |
| June 12, 1990 | K902267 | BLOOD GASES/PC02, PO2 ANALYSIS PRODUCTS | CHL | Substantially Equivalent | Phoenix Diagnostics, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Controls For Blood-Gases, (Assayed And Unassayed)
- All makers of Detergent
- All makers of General Purpose Reagent
- All makers of Multi-Analyte Controls, All Kinds (Assayed)
- All makers of Electrode, Ion Specific, Potassium
- All makers of Electrode, Ion-Specific, Chloride
Updated November 15, 2002. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.