Definition: Diabetes Take Home Kit
Device Type ID | 2863 |
Device Name | Diabetes Take Home Kit |
Physical State | N/a |
Technical Method | N/a |
Target Area | N/a |
Review Panel | General Hospital |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
Submission Type | Enforcement Discretion |
FDA Device Classification | Class Not Classified Medical Device |
Product Code | OSS |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2863 |
Device | Diabetes Take Home Kit |
Product Code | OSS |