Source document or public record
FDA 510(k) K192247 — Steripath Gen2 Blood Collection System
FDA 510(k) index record K192247. Device: Steripath Gen2 Blood Collection System. Applicant as listed: Magnolia Medical Technologies, Inc.. Decision date: 2020-02-28.
Source
"device_name": "Steripath Gen2 Blood Collection 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 K192247.
Device name: Steripath Gen2 Blood Collection System. Applicant as listed: Magnolia Medical Technologies, Inc..
Decision date: 2020-02-28. Decision wording: Substantially Equivalent.
Product code: JKA. Regulation: 21 CFR 862.1675. Medical specialty: Clinical Chemistry.
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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