Phoenix Diagnostics
ISE Diluent for Roche / Hitachi 704, 902, and P800 Series Chemistry Systems
2manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
Record
| Listed by | Phoenix Diagnostics, Inc., United States |
|---|---|
| FDA product code | JGS |
| Device type | Electrode, Ion Specific, Sodium |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1665 |
| Establishment | Manufacturer |
| 510(k) | K013451 |
| Record published | 2017-04-25 |
| Record revised | 2020-03-30 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 15 to 30 °C; Storage environment temperature 15 to 30 °C |
| Packaging | Case of 6, case of 4 |
| Sizes | Total volume 1000 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 16-200 | Total Volume 1000 ml | In distribution |
| 21-105 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stat Profile | Nova Biomedical Corporation | 13 |
| i-STAT | Abbott Point OF Care Inc. | 9 |
| AU | Beckman Coulter, Inc. | 8 |
| GEM Premier ChemSTAT PAK Na+,K+,Ca++,Cl-, Glu, Crea, BUN, tCO2, Hct, Lac,pH,pCO2 | Instrumentation Laboratory SPA | 8 |
| Nova | Nova Biomedical Corporation | 6 |
| Phoenix Diagnostics, Inc. | Phoenix Diagnostics, Inc. | 5 |
| Sodium Electrode | Roche Diagnostics Gmbh | 4 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 3 |
| Architect | Abbott Laboratories | 3 |
| Synermed® | Infrared Laboratory Systems LLC | 3 |
| Sodium Electrode | Diamond Diagnostics Inc. | 3 |
| Sodium Electrode | Medica Corp. | 2 |
Showing 12 of 88. All products under Electrode, Ion Specific, Sodium
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K020364 | 2002-06-04 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.