Source document or public record
FDA 510(k) K243144 — X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application
FDA 510(k) index record K243144. Device: X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application. Applicant as listed: Scopio Labs , Ltd.. Decision date: 2025-06-27.
Source
"device_name": "X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application"
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
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FDA 510(k) public index record K243144.
Device name: X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application. Applicant as listed: Scopio Labs , Ltd..
Decision date: 2025-06-27. Decision wording: Substantially Equivalent.
Product code: JOY. Regulation: 21 CFR 864.5260. 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.
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