| Device Type ID | 388 |
| Device Name | Coulometric, 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 | JFS |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 388 |
| Device | Coulometric, Chloride |
| Product Code | JFS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Chloride Test System. |
| CFR Regulation Number | 862.1170 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Siemens Healthcare Diagnostics Inc | III | Sep-30-2016 |