Panels › Microbiology › Product code PEO · Class 2
Fungal Organisms, Nucleic Acid-Based Assay
Regulation 866.3365
0510(k)s in 12 months (2 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PEO
| Company | 510(k)s | Recalls |
|---|---|---|
| Genmark Diagnostics, Incorporated | 1 | 0 |
| Luminex Corporation | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 4, 2024 | K240627 | LIAISON PLEX Yeast Blood Culture Assay Luminex Corporation | PEO |
| Dec 21, 2018 | K182690 | ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel Genmark Diagnostics, Incorporated | PEO |
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