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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 the device name listed in this FDA 510(k) record. The listed applicant is Luminex Corporation. It received FDA 510(k) clearance on 2024-03-01 under 510(k) 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. The listed applicant is Luminex Corporation. The 510(k) number is K233410.

When did LIAISON PLEX Respiratory Flex Assay receive FDA 510(k) clearance?

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

Who is the listed applicant for LIAISON PLEX Respiratory Flex 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 Respiratory Flex Assay?

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

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 AssayK243013LIAISON PLEX Gram-Negative Blood Culture AssayK240627LIAISON PLEX Yeast Blood Culture AssayK191742ARIES MRSA AssayK172402ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit

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Related Devices (Code: QOF)

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.

K252932Fast PCR Mini Respiratory PanelAutonomous Medical Devices IncorporatedK252269FINDER Flu A&B/SARS-CoV-2 TestBaebies, Inc.K251742VELO Respiratory TestLex Diagnostics LimitedK251978LIAISON NES FLU A/B, RSV & COVID-19Diasorin Molecular, LLCK252387Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)Diasorin Molecular, LLCK250080QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel MiniQIAGEN GmbH

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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