ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel— 510(k) K182690
Substantially EquivalentGenmark Diagnostics, Incorporated
FDA 510(k) clearance K182690 for ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel, Substantially Equivalent on 2018-12-21. Applicant: Genmark Diagnostics, Incorporated.
Clearance details
- Applicant
- Genmark Diagnostics, Incorporated
- Product code
- Code PEO
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.