K241919
- 510(k) number
- K241919
- Device name
- Innovita HCG Pregnancy Rapid Combo Test
- Applicant
- Innovita (Tangshan) Biological Technology Co., Ltd. CN
- Product code
- JHI — Visual, Pregnancy Hcg, Prescription Use
- Decision date
- 2024-08-02
- Date received
- 2024-07-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K241919.pdf
Official FDA record: K241919
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.