Simplexa COVID-19 Direct— 510(k) K212147
Substantially EquivalentDiasorin Molecular, LLC
FDA 510(k) clearance K212147 for Simplexa COVID-19 Direct, Substantially Equivalent on 2022-09-13. Applicant: Diasorin Molecular, LLC.
Clearance details
- Applicant
- Diasorin Molecular, LLC
- Product code
- Code QQX
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cypress, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.