Device Type ID | 5999 |
Device Name | High Performance Liquid Chromatography For Cyclosporine |
Regulation Description | Cyclosporine 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 | 862.1235 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | MGS |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |