Source document or public record
FDA 510(k) K192842 — HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High
FDA 510(k) index record K192842. Device: HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High. Applicant as listed: Eurotrol B.V.. Decision date: 2019-11-15.
Source
"device_name": "HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High"
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 K192842.
Device name: HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High. Applicant as listed: Eurotrol B.V..
Decision date: 2019-11-15. Decision wording: Substantially Equivalent.
Product code: GGM. Regulation: 21 CFR 864.8625. 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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