LIAISON PLEX Respiratory Flex Assay
FDA 510(k) clearance K233410 · decided 2024-03-01
Clearance details
- K-number
- K233410
- Device name
- LIAISON PLEX Respiratory Flex Assay
- Applicant
- Luminex Corporation
- Decision
- Substantially Equivalent
- Date received
- 2023-10-06
- Decision date
- 2024-03-01
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- QOF
- Device class
- 2
- Regulation number
- 866.3981
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Northbrook, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.