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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 a medical device manufactured by Luminex Corporation. It received FDA 510(k) clearance on 2025-04-18 under approval 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. It is manufactured by Luminex Corporation. The 510(k) number is K243013.

When was LIAISON PLEX Gram-Negative Blood Culture Assay approved by the FDA?

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

What company makes LIAISON PLEX Gram-Negative Blood Culture Assay?

LIAISON PLEX Gram-Negative Blood Culture Assay is manufactured by Luminex Corporation.

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.

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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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