K233624
- 510(k) number
- K233624
- Device name
- HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx
- Applicant
- Hangzhou Aichek Medical Technology Co., Ltd. CN
- Product code
- LCX — Kit, Test, Pregnancy, Hcg, Over The Counter
- Decision date
- 2024-04-12
- Date received
- 2023-11-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K233624.pdf
Official FDA record: K233624
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.