| Device Type ID | 6029 |
| Device Name | Enzyme Immunoassay, Diphenylhydantoin |
| Regulation Description | Diphenylhydantoin Test System. |
| Regulation Medical Specialty | Toxicology |
| Review Panel | Toxicology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.3350 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DIP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 6029 |
| Device | Enzyme Immunoassay, Diphenylhydantoin |
| Product Code | DIP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Diphenylhydantoin Test System. |
| CFR Regulation Number | 862.3350 [🔎] |
| Device Problems | |
|---|---|
Low Test Results | 2 |
Mechanical Problem | 2 |
High Test Results | 1 |
| Total Device Problems | 5 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ortho-Clinical Diagnostics | II | Jul-03-2018 |
| 2 | Ortho-Clinical Diagnostics | II | Dec-22-2017 |
| 3 | Ortho-Clinical Diagnostics | II | Oct-02-2014 |
| 4 | Siemens Healthcare Diagnostics, Inc | II | Feb-04-2014 |
| 5 | Siemens Healthcare Diagnostics, Inc. | II | Oct-29-2014 |