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FDA 510(k)

LIAISON PLEX Yeast Blood Culture Assay

K-Number: K240627 · 2024-06-04

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

Device Summary

LIAISON PLEX Yeast 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 2024-06-04 under 510(k) 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. The listed applicant is Luminex Corporation. The 510(k) number is K240627.

When did LIAISON PLEX Yeast Blood Culture Assay receive FDA 510(k) clearance?

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

Who is the listed applicant for LIAISON PLEX Yeast 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 Yeast Blood Culture Assay?

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

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.

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Related Devices (Code: PEO)

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.

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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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