Device Type ID | 6235 |
Device Name | Test System, Nicotine, Cotinine, Metabolites |
Regulation Description | Carbon Monoxide Test System. |
Regulation Medical Specialty | Toxicology |
Review Panel | Toxicology |
Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 862.3220 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | MRS |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Program |