K250117
- 510(k) number
- K250117
- Device name
- FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette
- Applicant
- Assure Tech., LLC DE · US
- Product code
- LCX — Kit, Test, Pregnancy, Hcg, Over The Counter
- Decision date
- 2025-02-13
- Date received
- 2025-01-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K250117.pdf
Official FDA record: K250117
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.