LIAISON PLEX Respiratory Flex Assay
FDA 510(k) K233410 · Luminex Corporation
Submission
- Device name
- LIAISON PLEX Respiratory Flex Assay
- Applicant
- Luminex Corporation
Northbrook, IL, US - Received
- October 6, 2023
- Decision date
- March 1, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QOF – Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3981
- Specialty
- Microbiology
A device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 and other microbial agents when in a multi-target test in human clinical respiratory specimens from…
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Questions and answers
When was LIAISON PLEX Respiratory Flex Assay cleared by the FDA?
LIAISON PLEX Respiratory Flex Assay (K233410) received a 510(k) decision of Substantially Equivalent on March 1, 2024, 147 days after the submission was received.
What is the product code of K233410?
The FDA product code is QOF – Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents, a Class II (moderate risk) device regulated under 21 CFR 866.3981.