The following data is part of a premarket notification filed by Phoenix Diagnostics, Inc. with the FDA for Phoenix Ise Reagents For Olympus Au Chemistry Systems.
| Device ID | K020148 |
| 510k Number | K020148 |
| Device Name: | PHoenix ISE Reagents FOR Olympus AU Chemistry Systems |
| Classification | Electrode, Ion-specific, Chloride |
| Applicant | PHOENIX DIAGNOSTICS, INC. 8 TECH CIRCLE Natick, MA 01760 |
| Contact | Ram Nunna |
| Correspondent | Ram Nunna PHOENIX DIAGNOSTICS, INC. 8 TECH CIRCLE Natick, MA 01760 |
| Product Code | CGZ |
| Subsequent Product Code | CEM |
| Subsequent Product Code | JGS |
| CFR Regulation Number | 862.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-16 |
| Decision Date | 2002-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10853366007018 | K020148 | 000 |
| 10853366007032 | K020148 | 000 |
| 10853366007049 | K020148 | 000 |
| 10853366007056 | K020148 | 000 |
| 10853366007070 | K020148 | 000 |
| 10853366007087 | K020148 | 000 |
| 00853366007103 | K020148 | 000 |
| 00853366007110 | K020148 | 000 |
| 00853366007127 | K020148 | 000 |
| 00853366007134 | K020148 | 000 |
| 10853366007025 | K020148 | 000 |