Company ยท US
Phoenix Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 2002. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | 5 |
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | 5 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 5 |
| CGZ | Electrode, Ion-Specific, Chloride | 2 |
| JJR | Electrolyte Controls (Assayed And Unassayed) | 2 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 1 |
| JGS | Electrode, Ion Specific, Sodium | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 15, 2002 | K023268 | PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS Phoenix Diagnostics, Inc. | JIX |
| Jun 4, 2002 | K020364 | PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS Phoenix Diagnostics, Inc. | JGS |
| Feb 4, 2002 | K020148 | pHoenix ISE Reagents FOR Olympus AU Chemistry Systems Phoenix Diagnostics, Inc. | CGZ |
| Feb 1, 2002 | K020129 | PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE Phoenix Diagnostics, Inc. | JIX |
| Dec 18, 2001 | K013451 | PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES Phoenix Diagnostics, Inc. | CGZ |
| Nov 7, 2001 | K012987 | PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER Phoenix Diagnostics, Inc. | JIX |
| Oct 9, 2001 | K012509 | PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMISTRY SYSTEM Phoenix Diagnostics, Inc. | JIX |
| May 13, 1996 | K960592 | ELECTROLYTE STANDARDS Phoenix Diagnostics, Inc. | JJR |
| Jan 17, 1995 | K945860 | SPECTRUM CO-OXIMETER LINEARITY CONTROL Phoenix Diagnostics, Inc. | JJS |
| Jul 14, 1992 | K920285 | BLOOD GAS/ISE LINEARITY CONTROL Phoenix Diagnostics, Inc. | JJS |
| Sep 6, 1991 | K912718 | ENZYME LINEARITY CONTROL Phoenix Diagnostics, Inc. | JJY |
| Dec 6, 1990 | K904075 | CLINICAL CHEMISTRY CONTROL Phoenix Diagnostics, Inc. | JJY |
| Jul 31, 1990 | K902675 | MULTI ANALYTE MIXTURE, CALIBRATORS Phoenix Diagnostics, Inc. | JIX |
| Jul 19, 1990 | K902616 | BILIRUBIN CONTROL Phoenix Diagnostics, Inc. | JJY |
| Jul 19, 1990 | K902094 | BLOOD GAS/ISE CONTROLS Phoenix Diagnostics, Inc. | JJY |
| Jun 12, 1990 | K902267 | BLOOD GASES/PC02, PO2 ANALYSIS PRODUCTS Phoenix Diagnostics, Inc. | CHL |
| Jun 12, 1990 | K902095 | BLOOD GAS/ELECTROLYTE/CO-OXIMETER CONTROLS Phoenix Diagnostics, Inc. | JJY |
| Jun 6, 1990 | K902266 | ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED) Phoenix Diagnostics, Inc. | JJR |
| Jun 6, 1990 | K901985 | BLOOD GAS CONTROLS Phoenix Diagnostics, Inc. | JJS |
| May 31, 1990 | K901986 | CO-OXIMETER CONTROLS Phoenix Diagnostics, Inc. | JJS |
| May 31, 1990 | K901976 | BLOOD GAS/CO-OXIMETRY CONTROL Phoenix Diagnostics, Inc. | JJS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||