DHX
- Product code
- DHX
- Device name
- System, Test, Carcinoembryonic Antigen
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.6010
- Medical specialty
- Immunology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 28
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K223921 | 2023-09-22 | Beckman Coulter, Inc. | Access CEA |
Official FDA classification page: DHX
Classification and pathway per current FDA publications. Data from openFDA (CC0).