K252228
- 510(k) number
- K252228
- Device name
- Seaman Pro/Seaman
- Applicant
- Checkcells, Inc. CA · US
- Product code
- POV — Semen Analysis Device
- Decision date
- 2026-04-09
- Date received
- 2025-07-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K252228.pdf
Official FDA record: K252228
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.