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FDA 510(k)

LIAISON PLEX Gram-Negative Blood Culture Assay

K-Number: K243013 · 2025-04-18

ApplicantLuminex Corporation
Decision Date2025-04-18
Product CodePEN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LIAISON PLEX Gram-Negative Blood Culture Assay is the device name listed in this FDA 510(k) record. The listed applicant is Luminex Corporation. It received FDA 510(k) clearance on 2025-04-18 under 510(k) number K243013. The device is classified under product code PEN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIAISON PLEX Gram-Negative Blood Culture Assay?

LIAISON PLEX Gram-Negative Blood Culture Assay is a medical device that received FDA 510(k) clearance on 2025-04-18. The listed applicant is Luminex Corporation. The 510(k) number is K243013.

When did LIAISON PLEX Gram-Negative Blood Culture Assay receive FDA 510(k) clearance?

LIAISON PLEX Gram-Negative Blood Culture Assay received FDA 510(k) clearance on 2025-04-18, under 510(k) number K243013.

Who is the listed applicant for LIAISON PLEX Gram-Negative Blood Culture Assay?

The FDA 510(k) record lists Luminex Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIAISON PLEX Gram-Negative Blood Culture Assay?

The FDA product code for LIAISON PLEX Gram-Negative Blood Culture Assay is PEN.

Other records listing Luminex Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253722LIAISON PLEX Gastrointestinal Flex AssayK243490LIAISON PLEX Gram-Positive Blood Culture AssayK240627LIAISON PLEX Yeast Blood Culture AssayK233410LIAISON PLEX Respiratory Flex AssayK191742ARIES MRSA AssayK172402ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit

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Related Devices (Code: PEN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243759BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))Biofire Diagnostics, LLCK213236ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelGenmark Diagnostics, IncorporatedK193519BioFire Blood Culture Identification 2 (BCID2) PanelBiofire Diagnostics, LLCK190341iC-GN iC-Cassette for use on the iC-SystemIcubate, Inc.K182619ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelGenmark Diagnostics, IncorporatedK181493FilmArray Blood Culture Identification (BCID) PanelBiofire Diagnostics, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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