K241394
- 510(k) number
- K241394
- Device name
- iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip
- Applicant
- Andon Health Co, Ltd. CN
- Product code
- LCX — Kit, Test, Pregnancy, Hcg, Over The Counter
- Decision date
- 2024-12-20
- Date received
- 2024-05-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K241394.pdf
Official FDA record: K241394
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.