Source document or public record
FDA 510(k) K243013 — LIAISON PLEX Gram-Negative Blood Culture Assay
FDA 510(k) index record K243013. Device: LIAISON PLEX Gram-Negative Blood Culture Assay. Applicant as listed: Luminex Corporation. Decision date: 2025-04-18.
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"device_name": "LIAISON PLEX Gram-Negative Blood Culture Assay"
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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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K243013.
Device name: LIAISON PLEX Gram-Negative Blood Culture Assay. Applicant as listed: Luminex Corporation.
Decision date: 2025-04-18. Decision wording: Substantially Equivalent.
Product code: PEN. Regulation: 21 CFR 866.3365. 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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