QYD — Adalimumab Assay Class II
Classification Details
- Product Code
- QYD
- Device Class
- Class II
- Regulation Number
- 862.3115
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Definition
An in vitro diagnostic device intended for the measurement of adalimumab, an anti-tumor necrosis factor alpha monoclonal antibody
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN220023 | procisedx | Procise ADL | September 29, 2023 |