510(k) DEN210056
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- September 29, 2023
- Date Received
- December 8, 2021
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Infliximab Test System
- Device Class
- Class II
- Regulation Number
- 862.3115
- Review Panel
- TX
- Submission Type
An infliximab test system intended for the measurement of an infliximab as an aid in the management of patients with Crohns disease or ulcerative colitis.