LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit— 510(k) K260333
Substantially EquivalentDiasorin Molecular, LLC
FDA 510(k) clearance K260333 for LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit, Substantially Equivalent on 2026-06-15. Applicant: Diasorin Molecular, LLC. Device class: 2.
Clearance details
- Applicant
- Diasorin Molecular, LLC
- Product code
- Code PGX
- Device class
- Class 2
- Regulation
- 21 CFR 866.2680
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Location
- Cypress, CA, US
Recent devices under product code PGX
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- DEN230092 — Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)
- K220963 — Simplexa COVID-19 & Flu A/B Direct
- K202755 — Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack
Data sourced from openFDA. This site is unofficial and independent of the FDA.