Eonis SMA kit— 510(k) K262893
Substantially EquivalentRevvity, Inc.
FDA 510(k) clearance K262893 for Eonis SMA kit, Substantially Equivalent on 2026-09-30. Applicant: Revvity, Inc.. Device class: 2.
Summary
The Eonis SMA kit is a newborn screening test for spinal muscular atrophy. Product code QUE covers exactly that category: SMA newborn screening test systems.
Class II, 21 CFR 866.5980. The advisory panel is listed as Immunology and the review panel as Clinical Chemistry. Revvity, Inc. filed it as a Traditional 510(k).
Revvity is based in Waltham, Massachusetts. Review took 44 days (August 17 to September 30, 2026).
Clearance details
- Applicant
- Revvity, Inc.
- Product code
- Product code QUE
- Device class
- Class 2
- Regulation
- 21 CFR 866.5980
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waltham, MA, US
Recent devices under product code QUE
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