| Device Type ID | 434 |
| Device Name | Enzymatic 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 | JIF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 434 |
| Device | Enzymatic Method, Ammonia |
| Product Code | JIF |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Ammonia Test System. |
| CFR Regulation Number | 862.1065 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ROCHE DIAGNOSTICS OPERATIONS (RDO) | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Low Test Results | 9 |
High Test Results | 5 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Incorrect Or Inadequate Test Results | 3 |
Visual Prompts Will Not Clear | 2 |
Gauges/Meters | 1 |
Incorrect Measurement | 1 |
Device Subassembly | 1 |
| Total Device Problems | 25 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Sekisui Diagnostics P.E.I. Inc. | II | Jan-23-2017 |
| 2 | Sentinel CH SpA | II | Oct-26-2015 |
| 3 | Siemens Healthcare Diagnostics, Inc. | II | Oct-11-2018 |
| 4 | Siemens Healthcare Diagnostics, Inc. | II | May-04-2018 |