The following data is part of a premarket notification filed by Phoenix Diagnostics, Inc. with the FDA for Phoenoix Ise Reagents For Roche Hitachi, Models 700/900 Series.
| Device ID | K013451 |
| 510k Number | K013451 |
| Device Name: | PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES |
| 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 | JGS |
| Subsequent Product Code | JIX |
| CFR Regulation Number | 862.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-18 |
| Decision Date | 2001-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853366007349 | K013451 | 000 |
| 00853366007158 | K013451 | 000 |
| 00853366007165 | K013451 | 000 |
| 10853366007179 | K013451 | 000 |
| 00853366007189 | K013451 | 000 |
| 00853366007196 | K013451 | 000 |
| 10853366007209 | K013451 | 000 |
| 10853366007216 | K013451 | 000 |
| 10853366007223 | K013451 | 000 |
| 08533660072244 | K013451 | 000 |
| 00853366007271 | K013451 | 000 |
| 00853366007288 | K013451 | 000 |
| 10853366007292 | K013451 | 000 |
| 00853366007301 | K013451 | 000 |
| 00853366007318 | K013451 | 000 |
| 00853366007325 | K013451 | 000 |
| 00853366007332 | K013451 | 000 |
| 10853366007148 | K013451 | 000 |