K233174
- 510(k) number
- K233174
- Device name
- FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream
- Applicant
- Assure Tech. (Hangzhou) Co, Ltd. CN
- Product code
- LCX — Kit, Test, Pregnancy, Hcg, Over The Counter
- Decision date
- 2024-02-05
- Date received
- 2023-09-28
- 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: K233174.pdf
Official FDA record: K233174
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.