SP90
ABL90 FLEX Solution pack, US
2manufacturers in China registered for this device type
1catalogue number
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 | Radiometer Medical APS, Denmark |
|---|---|
| FDA product code | CGZ |
| Device type | Electrode, Ion-Specific, Chloride |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1170 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K240998 |
| Record published | 2026-07-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Labeling does not contain MRI Safety information; Storage environment humidity 20 to 80 % RH; Storage environment temperature 2 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 944-657 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stat Profile | Nova Biomedical Corporation | 14 |
| Nova | Nova Biomedical Corporation | 8 |
| Architect | Abbott Laboratories | 6 |
| Chloride Electrode | Roche Diagnostics Gmbh | 3 |
| Chloride Electrode | Medica Corp. | 3 |
| Chloride Electrode | Diamond Diagnostics Inc. | 3 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 2 |
| I.S.E. CL | Randox Laboratories Limited | 2 |
| Phoenix Diagnostics, Inc. | Phoenix Diagnostics, Inc. | 2 |
| Na/K/Cl Solution Pack | Medica Corp. | 2 |
| Ready Sensor™ Gold Reference Sensor Refill | Siemens Healthcare Diagnostics Inc | 1 |
| I.S.E. REF | Randox Laboratories Limited | 1 |
Showing 12 of 51. All products under Electrode, Ion-Specific, Chloride
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.