510(k) DEN200044
- Device
- Eonis SCID-SMA Kit
- Applicant
- Perkinelmer, Inc.
- 510(k) number
- DEN200044
- Product code
- QUE
- Decision
- Unknown (DENG)
- Decision date
- 2022-11-09
- Date received
- 2020-07-08
- Regulation
- 866.5980
- Classification name
- Spinal Muscular Atrophy Newborn Screening Test System
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Casey Fox
- Address
- 940 Winter St. Waltham MA US 02451 02451
FDA Registration Numbers#
- 8043909
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QUE#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262893 | Eonis™ SMA kit | Revvity, Inc. | 2026-09-30 |