DHA
- Product code
- DHA
- Device name
- System, Test, Human Chorionic Gonadotropin
- Device class
- Class 2
- 21 CFR
- 21 CFR 862.1155
- Medical specialty
- Clinical Chemistry
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 72 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K233581 | 2024-05-08 | Ortho Clinical Diagnostics | VITROS Immunodiagnostic Products Total ß-hCG II Reag… | |
| K223690 | 2023-12-11 | Shenzhen Yhlo Biotech Co., Ltd. | iFlash-HCG; Chemiluminescence Immunoassay Analyzer (… |
Official FDA classification page: DHA
Classification and pathway per current FDA publications. Data from openFDA (CC0).