510(k) clearance
Eonis™ SMA kit
- 510(k) number
- K262893
- Applicant
- Revvity, Inc.
- Decision date
- Sep 30, 2026
- Date received
- Aug 17, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- QUE
- Device type
- Spinal Muscular Atrophy Newborn Screening Test System
- Device class
- Class II
- Regulation
- 21 CFR 866.5980
- Advisory committee
- Immunology
- Statement or summary
- Summary
- Third party
- N
- Location
- Waltham, MA, US