K241626
- 510(k) number
- K241626
- Device name
- SperSort Sperm Sorting Chip (IPG02)
- Applicant
- Ipreg Incorporation TW
- Product code
- MQK — Labware, Assisted Reproduction
- Decision date
- 2025-02-20
- Date received
- 2024-06-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K241626.pdf
Official FDA record: K241626
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.