Device Type ID | 6010 |
Device Name | Test, Triglycerides, Over The Counter |
Regulation Description | Triglyceride Test System. |
Regulation Medical Specialty | Clinical Chemistry |
Review Panel | Toxicology |
Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
Submission Type | 510(k) |
CFR Regulation Number | 862.1705 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | NGO |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 6010 |
Device | Test, Triglycerides, Over The Counter |
Product Code | NGO |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Triglyceride Test System. |
CFR Regulation Number | 862.1705 [🔎] |