| Device Type ID | 432 |
| Device Name | Photometric Method, Ammonia |
| Regulation Description | Ammonia 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 | 862.1065 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | JID |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 432 |
| Device | Photometric Method, Ammonia |
| Product Code | JID |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Ammonia Test System. |
| CFR Regulation Number | 862.1065 [🔎] |
| Device Problems | |
|---|---|
Device Dislodged Or Dislocated | 1 |
| Total Device Problems | 1 |