| Device Type ID | 307 |
| Device Name | Electrode, Ion-specific, Chloride |
| Regulation Description | Chloride 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 | 862.1170 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | CGZ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 307 |
| Device | Electrode, Ion-specific, Chloride |
| Product Code | CGZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Chloride Test System. |
| CFR Regulation Number | 862.1170 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ABBOTT | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ABBOTT LABORATORIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ORTHO-CLINICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ORTHO-CLINICAL DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
High Test Results | 20 |
Electrode | 3 |
Low Test Results | 3 |
Tube | 1 |
Device Issue | 1 |
Membrane | 1 |
Incorrect Or Inadequate Test Results | 1 |
Non Reproducible Results | 1 |
| Total Device Problems | 31 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ortho-Clinical Diagnostics | III | Sep-17-2018 |
| 2 | Ortho-Clinical Diagnostics | III | Sep-14-2018 |