510(k) K182690
- Device
- EPlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel
- Applicant
- GenMark Diagnostics, Incorporated
- 510(k) number
- K182690
- Product code
- PEO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-12-21
- Date received
- 2018-09-27
- 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
- Beth Stofka
- Address
- 5964 La Pl. Ct. Carlsbad CA US 92008 92008
FDA Registration Numbers#
- 3010749841
- 3008632402
- 3004613294
- 3002773840
- 3006028115
Source Documents#
Other 510(k) Records For Product Code PEO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240627 | LIAISON PLEX Yeast Blood Culture Assay | Luminex Corporation | 2024-06-04 |
Legacy Summary#
summary
FDA Review#
Decision Summary