Selectra
Selectra: 2 catalogue numbers listed by VitalScientific B.V., Netherlands, under Electrode, Ion Specific, Potassium. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | VitalScientific B.V., Netherlands |
|---|---|
| FDA product code | CEM |
| Device type | Electrode, Ion Specific, Potassium |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1600 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K102647 |
| Record published | 2025-05-06 |
| Record revised | 2025-05-20 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2025-05-19 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ProS | In distribution | |
| ProS | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nova | Nova Biomedical Corporation | 8 |
| Stat Profile | Nova Biomedical Corporation | 7 |
| Potassium electrode | Roche Diagnostics Gmbh | 4 |
| Potassium Electrode | Diamond Diagnostics Inc. | 3 |
| Synermed® | Infrared Laboratory Systems LLC | 3 |
| Architect | Abbott Laboratories | 3 |
| Phoenix Diagnostics, Inc. | Phoenix Diagnostics, Inc. | 2 |
| I.S.E. K | Randox Laboratories Limited | 2 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 2 |
| Potassium Electrode | Medica Corp. | 2 |
| Na/K Solution Pack | Medica Corp. | 2 |
| FlexLab | Inpeco SA | 1 |
Showing 12 of 93. All products under Electrode, Ion Specific, Potassium
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.