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FDA 510(k)

LIAISON PLEX Respiratory Flex Assay

K-Number: K233410 · 2024-03-01

ApplicantLuminex Corporation
Decision Date2024-03-01
Product CodeQOF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LIAISON PLEX Respiratory Flex Assay is a medical device manufactured by Luminex Corporation. It received FDA 510(k) clearance on 2024-03-01 under approval number K233410. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIAISON PLEX Respiratory Flex Assay?

LIAISON PLEX Respiratory Flex Assay is a medical device that received FDA 510(k) clearance on 2024-03-01. It is manufactured by Luminex Corporation. The 510(k) number is K233410.

When was LIAISON PLEX Respiratory Flex Assay approved by the FDA?

LIAISON PLEX Respiratory Flex Assay received FDA 510(k) clearance on 2024-03-01, under approval number K233410.

What company makes LIAISON PLEX Respiratory Flex Assay?

LIAISON PLEX Respiratory Flex Assay is manufactured by Luminex Corporation.

What is the FDA product code for LIAISON PLEX Respiratory Flex Assay?

The FDA product code for LIAISON PLEX Respiratory Flex Assay is QOF.

Related Clinical Trials

NCT07513519 Impact of a Multiplex Respiratory PCR Test on Outcomes for Patients Presenting With Respiratory Illness in the Urgent Care Setting: A Hybrid-Effectiveness Quasi-Experimental Trial RECRUITING

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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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