ABL90 Flex
ABL90 FLEX, Analyzer without cassettes, cables, manuals etc.
2manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
3recalls on this code
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 | CEM |
| Device type | Electrode, Ion Specific, Potassium |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1600 |
| Establishment | Complaint-file establishment, Manufacturer |
| Record published | 2026-07-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Handling environment temperature 15 to 32 °C; Storage environment temperature -20 to 60 °C; Handling environment humidity 10 to 80 % RH; Special storage condition: Labeling does not contain MRI Safety information; Handling environment atmospheric pressure 70 to 107 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 393-097 | In distribution |
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 |
| Selectra | VitalScientific B.V. | 2 |
Showing 12 of 93. All products under Electrode, Ion Specific, Potassium
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K092686 | 2010-08-06 |
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-04-14 | Class II | Device Design | Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed. | Total 965 PC units World-wide (only 35 units in the U.S.) | |
| 2021-04-14 | Class II | Device Design | Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed. | Total=3,346 analyzers world-wide (only 2 analyzers within th | |
| 2020-02-03 | Class II | Software design | The firm received reports of occurrences where the barcode reader misinterpreted the contents of a locally printed barcode label used for entering patient ID or accession number into the analyzer in connection with a sample measurement. T | 12,822 units | 2022-09-20 |
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.