Simplexa COVID-19 & Flu A/B Direct— 510(k) K220963
Substantially EquivalentDiasorin Molecular, LLC
FDA 510(k) clearance K220963 for Simplexa COVID-19 & Flu A/B Direct, Substantially Equivalent on 2023-03-17. Applicant: Diasorin Molecular, LLC. Device class: 2.
Clearance details
- Applicant
- Diasorin Molecular, LLC
- Product code
- Code QOF
- Device class
- Class 2
- Regulation
- 21 CFR 866.3981
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cypress, CA, US
Recent devices under product code QOF
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view all- K260333 — LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit
- K252387 — Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)
- DEN230092 — Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)
- K202755 — Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack
- K212147 — Simplexa COVID-19 Direct
Data sourced from openFDA. This site is unofficial and independent of the FDA.