| Device Type ID | 6279 |
| Device Name | Enzyme Immunoassay, Methotrexate |
| Review Panel | Toxicology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | LAO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 6279 |
| Device | Enzyme Immunoassay, Methotrexate |
| Product Code | LAO |
| Device Problems | |
|---|---|
High Test Results | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
| Total Device Problems | 4 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Siemens Healthcare Diagnostics, Inc. | II | May-06-2016 |