Phoenix Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Phoenix Diagnostics, Inc.” (first 1990, latest 2002), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 46 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | 5 | 5 |
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | 5 | 5 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 5 | 5 |
| CGZ | Electrode, Ion-Specific, Chloride | 2 | 2 |
| JJR | Electrolyte Controls (Assayed And Unassayed) | 2 | 2 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 1 | 1 |
| JGS | Electrode, Ion Specific, Sodium | 1 | 1 |
Review panels
- Clinical Chemistry (21)
Most recent Phoenix Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023268 | PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS | JIX | 2002-11-15 | 46 |
| K020364 | PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS | JGS | 2002-06-04 | 120 |
| K020148 | pHoenix ISE Reagents FOR Olympus AU Chemistry Systems | CGZ | 2002-02-04 | 19 |
| K020129 | PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE | JIX | 2002-02-01 | 18 |
| K013451 | PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES | CGZ | 2001-12-18 | 61 |
| K012987 | PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER | JIX | 2001-11-07 | 62 |
| K012509 | PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMISTRY SYSTEM | JIX | 2001-10-09 | 64 |
| K960592 | ELECTROLYTE STANDARDS | JJR | 1996-05-13 | 91 |
| K945860 | SPECTRUM CO-OXIMETER LINEARITY CONTROL | JJS | 1995-01-17 | 47 |
| K920285 | BLOOD GAS/ISE LINEARITY CONTROL | JJS | 1992-07-14 | 174 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Phoenix Diagnostics, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Phoenix Biomedical Corp. (13 510(k)s)
- Phoenix Medical Technology, Inc. (11 510(k)s)
- Phoenix Glove Co. (6 510(k)s)
- Phoenix Dental, Inc. (5 510(k)s)
- Phoenix Bioengineering, Inc. (3 510(k)s)
- Phoenix Biotech Corp. (2 510(k)s)
- Phoenix Imaging (2 510(k)s)
- Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd. (2 510(k)s)
- Phoenix Corp. (1 510(k)s)
- Phoenix Instruments Div. (1 510(k)s)
- Phoenix Intl. Marketing, Inc. (1 510(k)s)
- Phoenix Laser Systems, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Phoenix Diagnostics, Inc.?
FDA lists 21 510(k) clearances under the applicant name “Phoenix Diagnostics, Inc.” (first 1990, latest 2002), across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Phoenix Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Phoenix Diagnostics, Inc. is 46 days.
Which FDA product codes appear under Phoenix Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are JIX (Calibrator, Multi-Analyte Mixture, 5); JJS (Controls For Blood-Gases, (Assayed And Unassayed), 5); JJY (Multi-Analyte Controls, All Kinds (Assayed), 5).
Next steps
- See all 21 Phoenix Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JIX, Phoenix Diagnostics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.