ePlex Instrument— 510(k) K163652
Substantially EquivalentGenmark Diagnostics, Incorporated
FDA 510(k) clearance K163652 for ePlex Instrument, Substantially Equivalent on 2017-06-09. Applicant: Genmark Diagnostics, Incorporated.
Clearance details
- Applicant
- Genmark Diagnostics, Incorporated
- Product code
- Code NSU
- Advisory panel
- Clinical Chemistry
- 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.