| Device Type ID | 295 |
| Device Name | Orthotoluidine, Glucose |
| Regulation Description | Glucose 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 | 862.1345 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | CGE |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 295 |
| Device | Orthotoluidine, Glucose |
| Product Code | CGE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Glucose Test System. |
| CFR Regulation Number | 862.1345 [🔎] |