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.
Summary
Diasorin Molecular's clearance covers the LIAISON NES Group A Strep and the LIAISON NES Group A Strep Control Swab Kit. They're filed under PGX, nucleic acid amplification systems for groups A, C, and G beta-hemolytic streptococcus, though the names refer only to Group A.
Class II, 21 CFR 866.2680. Microbiology is both the classification panel and the review panel. The submission type is listed as Dual Track.
Diasorin filed from Cypress, California. Review took 133 calendar days (February 2 to June 15, 2026).
Clearance details
- Applicant
- Diasorin Molecular, LLC
- Product code
- Product 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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Data sourced from openFDA. This site is unofficial and independent of the FDA.