Source document or public record
FDA 510(k) K201217 — HemoCue Hb 301 System
FDA 510(k) index record K201217. Device: HemoCue Hb 301 System. Applicant as listed: Hemocue AB. Decision date: 2020-08-04.
Source
"device_name": "HemoCue Hb 301 System"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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2026-10-20
2026-10-20
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FDA 510(k) public index record K201217.
Device name: HemoCue Hb 301 System. Applicant as listed: Hemocue AB.
Decision date: 2020-08-04. Decision wording: Substantially Equivalent.
Product code: GKR. Regulation: 21 CFR 864.5620. 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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