510(k) K262893
- Device
- Eonis™ SMA kit
- Applicant
- Revvity, Inc.
- 510(k) number
- K262893
- Product code
- QUE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-09-30
- Date received
- 2026-08-17
- Regulation
- 866.5980
- Classification name
- Spinal Muscular Atrophy Newborn Screening Test System
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Lisa Vershave
- Address
- 77 4th Ave. Waltham MA US 02451 02451
FDA Registration Numbers#
- 8043909
Source Documents#
Other 510(k) Records For Product Code QUE#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN200044 | Eonis SCID-SMA Kit | Perkinelmer, Inc. | 2022-11-09 |