510(k) K240627
- Device
- LIAISON PLEX Yeast Blood Culture Assay
- Applicant
- Luminex Corporation
- 510(k) number
- K240627
- Product code
- PEO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-06-04
- Date received
- 2024-03-06
- Regulation
- 866.3365
- Classification name
- Fungal Organisms, Nucleic Acid-Based Assay
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Sarah Herzog
- Address
- 4088 Commercial Ave. Northbrook IL US 60062 60062
FDA Registration Numbers#
- 3010749841
- 3008632402
- 3004613294
- 3002773840
- 3006028115
Source Documents#
Other 510(k) Records For Product Code PEO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K182690 | ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel | Genmark Diagnostics, Incorporated | 2018-12-21 |