Phoenix Diagnostics, Inc.
Natick, MA, US
PHOENIX DIAGNOSTICS, INC. appears in FDA device records in Natick, MA. FDA records list 21 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 21 510(k) clearances for Phoenix Diagnostics, Inc. between 1990 and 2002. The busiest year on record is 1990, with 10. The most recent is 2002, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 10 |
| 1991 | 1 |
| 1992 | 1 |
| 1995 | 1 |
| 1996 | 1 |
| 2001 | 3 |
| 2002 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K023268 | PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS | JIX | Substantially Equivalent | |
| K020364 | PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS | JGS | Substantially Equivalent | |
| K020148 | pHoenix ISE Reagents FOR Olympus AU Chemistry Systems | CGZ | Substantially Equivalent | |
| K020129 | PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE | JIX | Substantially Equivalent | |
| K013451 | PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES | CGZ | Substantially Equivalent | |
| K012987 | PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER | JIX | Substantially Equivalent | |
| K012509 | PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMISTRY SYSTEM | JIX | Substantially Equivalent | |
| K960592 | ELECTROLYTE STANDARDS | JJR | Substantially Equivalent | |
| K945860 | SPECTRUM CO-OXIMETER LINEARITY CONTROL | JJS | Substantially Equivalent | |
| K920285 | BLOOD GAS/ISE LINEARITY CONTROL | JJS | Substantially Equivalent | |
| K912718 | ENZYME LINEARITY CONTROL | JJY | Substantially Equivalent | |
| K904075 | CLINICAL CHEMISTRY CONTROL | JJY | Substantially Equivalent | |
| K902675 | MULTI ANALYTE MIXTURE, CALIBRATORS | JIX | Substantially Equivalent | |
| K902616 | BILIRUBIN CONTROL | JJY | Substantially Equivalent | |
| K902094 | BLOOD GAS/ISE CONTROLS | JJY | Substantially Equivalent | |
| K902267 | BLOOD GASES/PC02, PO2 ANALYSIS PRODUCTS | CHL | Substantially Equivalent | |
| K902095 | BLOOD GAS/ELECTROLYTE/CO-OXIMETER CONTROLS | JJY | Substantially Equivalent | |
| K902266 | ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED) | JJR | Substantially Equivalent | |
| K901985 | BLOOD GAS CONTROLS | JJS | Substantially Equivalent | |
| K901986 | CO-OXIMETER CONTROLS | JJS | Substantially Equivalent | |
| K901976 | BLOOD GAS/CO-OXIMETRY CONTROL | JJS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1222035 | 1222035 | PHOENIX DIAGNOSTICS, INC. | 8 TECH CIRCLE, Natick, MA 01760 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JIXCalibrator, Multi-Analyte Mixture
- JJSControls For Blood-Gases, (Assayed And Unassayed)
- JCBDetergent
- CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- CEMElectrode, Ion Specific, Potassium
- JGSElectrode, Ion Specific, Sodium
- CGZElectrode, Ion-Specific, Chloride
- JJRElectrolyte Controls (Assayed And Unassayed)
- PPMGeneral Purpose Reagent
- JJYMulti-Analyte Controls, All Kinds (Assayed)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain