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FDA 510(k)

LIAISON PLEX Yeast Blood Culture Assay

K-Number: K240627 · 2024-06-04

Decision Date2024-06-04
Product CodePEO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LIAISON PLEX Yeast Blood Culture Assay is a medical device manufactured by Luminex Corporation. It received FDA 510(k) clearance on 2024-06-04 under approval number K240627. The device is classified under product code PEO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIAISON PLEX Yeast Blood Culture Assay?

LIAISON PLEX Yeast Blood Culture Assay is a medical device that received FDA 510(k) clearance on 2024-06-04. It is manufactured by Luminex Corporation. The 510(k) number is K240627.

When was LIAISON PLEX Yeast Blood Culture Assay approved by the FDA?

LIAISON PLEX Yeast Blood Culture Assay received FDA 510(k) clearance on 2024-06-04, under approval number K240627.

What company makes LIAISON PLEX Yeast Blood Culture Assay?

LIAISON PLEX Yeast Blood Culture Assay is manufactured by Luminex Corporation.

What is the FDA product code for LIAISON PLEX Yeast Blood Culture Assay?

The FDA product code for LIAISON PLEX Yeast Blood Culture Assay is PEO.

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Official Source

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