DEN210056 is an FDA 510(k) submission for the Procise IFX. This device is classified as a Infliximab Test System (Class II - Special Controls, product code QXT).
Submitted by Procisedx, Inc. (San Diego, US). The FDA issued a Not Cleared (DENG) decision on September 29, 2023.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3115. 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..
| 510(k) Number | DEN210056 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | December 08, 2021 |
| Decision Date | September 29, 2023 |
| Days to Decision | 660 days |
| Submission Type | Direct |
| Review Panel | Toxicology (TX) |
| Summary | - |
| Product Code | QXT - Infliximab Test System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3115 |
| Definition | 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. |