Documento fuente o registro público
FDA 510(k) K222148 — HemoScreen Hematology Analyzer
FDA 510(k) index record K222148. Device: HemoScreen Hematology Analyzer. Applicant as listed: Pixcell Medical Technologies, Ltd.. Decision date: 2023-08-16.
Fuente
"device_name": "HemoScreen Hematology Analyzer"
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Review and references
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2026-10-20
2026-10-28
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FDA 510(k) public index record K222148.
Device name: HemoScreen Hematology Analyzer. Applicant as listed: Pixcell Medical Technologies, Ltd..
Decision date: 2023-08-16. Decision wording: Substantially Equivalent.
Product code: GKZ. 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.
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