JHI
- Product code
- JHI
- Device name
- Visual, Pregnancy Hcg, Prescription Use
- 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)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 375 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K241919 | 2024-08-02 | Innovita (Tangshan) Biological Technol… | Innovita HCG Pregnancy Rapid Combo Test |
Official FDA classification page: JHI
Classification and pathway per current FDA publications. Data from openFDA (CC0).