510(k) DEN210056
DEN210056 is an FDA 510(k) premarket notification submitted by Procisedx, Inc. for the device "Procise IFX". The FDA issued a decision of De Novo Granted on September 29, 2023. The device falls under product code QXT (Infliximab Test System), a Class II device regulated under 21 CFR 862.3115. Procisedx, Inc. has at least 1 other 510(k) clearance on record.
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.