| Device Type ID | 538 |
| Device Name | Infrared Spectroscopy Measurement, Urinary Calculi (stone) |
| Regulation Description | Urinary Calculi (stones) 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) Exempt |
| CFR Regulation Number | 862.1780 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | JNP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |