LIAISON PLEX Yeast Blood Culture Assay
FDA 510(k) clearance K240627 · decided 2024-06-04
Clearance details
- K-number
- K240627
- Device name
- LIAISON PLEX Yeast Blood Culture Assay
- Applicant
- Luminex Corporation
- Decision
- Substantially Equivalent
- Date received
- 2024-03-06
- Decision date
- 2024-06-04
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- PEO
- Device class
- 2
- Regulation number
- 866.3365
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Northbrook, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel (K182690) | Genmark Diagnostics, Incorporated | 2018-12-21 |
Recalls involving this device
No recalls on record reference this clearance.