Source document or public record
FDA 510(k) K191967 — Unyvero LRT BAL Application
FDA 510(k) index record K191967. Device: Unyvero LRT BAL Application. Applicant as listed: Curetis GmbH. Decision date: 2019-12-20.
Source
"device_name": "Unyvero LRT BAL Application"
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 K191967.
Device name: Unyvero LRT BAL Application. Applicant as listed: Curetis GmbH.
Decision date: 2019-12-20. Decision wording: Substantially Equivalent.
Product code: QBH. Regulation: 21 CFR 866.3985. Medical specialty: Microbiology.
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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