DEN210056
- 510(k) number
- DEN210056
- Device name
- Procise IFX
- Applicant
- Procisedx, Inc. CA · US
- Product code
- QXT — Infliximab Test System
- Decision date
- 2023-09-29
- Date received
- 2021-12-08
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Clinical Toxicology
Official FDA record: DEN210056
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.