Source document or public record
FDA 510(k) K220828 — SQA-iO Sperm Quality Analyzer
FDA 510(k) index record K220828. Device: SQA-iO Sperm Quality Analyzer. Applicant as listed: Medical Electronic Systems , Ltd.. Decision date: 2023-08-07.
Source
"device_name": "SQA-iO Sperm Quality Analyzer"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K220828.
Device name: SQA-iO Sperm Quality Analyzer. Applicant as listed: Medical Electronic Systems , Ltd..
Decision date: 2023-08-07. Decision wording: Substantially Equivalent.
Product code: POV. Regulation: 21 CFR 864.5220. Medical specialty: Hematology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
Interested in these solutions?
Submit a sourcing request with the assays, volumes, and timeline of your own project.