The following data is part of a premarket notification filed by Phoenix Diagnostics, Inc. with the FDA for Phoenix Ise Reagents For Beckman Cx Systems.
| Device ID | K020364 |
| 510k Number | K020364 |
| Device Name: | PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | PHOENIX DIAGNOSTICS, INC. 8 TECH CIRCLE Natick, MA 01760 |
| Contact | Ran Nunna |
| Correspondent | Ran Nunna PHOENIX DIAGNOSTICS, INC. 8 TECH CIRCLE Natick, MA 01760 |
| Product Code | JGS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | CHL |
| Subsequent Product Code | JIX |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-04 |
| Decision Date | 2002-06-04 |
| Summary: | summary |