Device Type ID | 6092 |
Device Name | Digoxin Control Serum, Ria |
Regulation Description | Clinical Toxicology Control Material. |
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 | 862.3280 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | DMP |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Program |