Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)— 510(k) K252387
Substantially EquivalentDiasorin Molecular, LLC
FDA 510(k) clearance K252387 for Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460), Substantially Equivalent on 2025-10-30. Applicant: Diasorin Molecular, LLC.
Clearance details
- Applicant
- Diasorin Molecular, LLC
- Product code
- Code QOF
- 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.