| Device Type ID | 268 |
| Device Name | Electrode, Ion Specific, Potassium |
| Regulation Description | Potassium Test System. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.1600 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | CEM |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 268 |
| Device | Electrode, Ion Specific, Potassium |
| Product Code | CEM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Potassium Test System. |
| CFR Regulation Number | 862.1600 [🔎] |
| Device Problems | |
|---|---|
High Test Results | 31 |
Low Test Results | 23 |
Incorrect Or Inadequate Test Results | 13 |
Adverse Event Without Identified Device Or Use Problem | 6 |
Mechanical Problem | 4 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 3 |
Electrode | 3 |
Nozzle | 2 |
Probe | 2 |
Failure To Align | 1 |
Device Subassembly | 1 |
Cover | 1 |
Tube | 1 |
Spring | 1 |
False Device Output | 1 |
Device Issue | 1 |
Diaphragm | 1 |
Low Readings | 1 |
Cap | 1 |
Cups | 1 |
Seal | 1 |
Non Reproducible Results | 1 |
| Total Device Problems | 100 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Abbott Laboratories | II | Jun-27-2015 |
| 2 | Inpeco S.A. | II | Nov-16-2016 |
| 3 | Roche Diagnostics Corporation | II | May-03-2018 |
| 4 | Siemens Healthcare Diagnostics, Inc. | II | Apr-07-2015 |