| Device Type ID | 407 |
| Device Name | Colorimetric Method, Triglycerides |
| Regulation Description | Triglyceride 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 | 862.1705 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | JGY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 407 |
| Device | Colorimetric Method, Triglycerides |
| Product Code | JGY |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Triglyceride Test System. |
| CFR Regulation Number | 862.1705 [🔎] |
| Device Problems | |
|---|---|
High Test Results | 5 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Probe | 2 |
Mechanical Problem | 1 |
Filter | 1 |
Cell | 1 |
Low Test Results | 1 |
Device Subassembly | 1 |
Lamp | 1 |
Diaphragm | 1 |
Valve | 1 |
Washer | 1 |
| Total Device Problems | 19 |