Panels › Immunology › Product code QUE · Class 2
Spinal Muscular Atrophy Newborn Screening Test System
Regulation 866.5980
1510(k)s in 12 months (2 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QUE
| Company | 510(k)s | Recalls |
|---|---|---|
| Perkinelmer, Inc. | 1 | 0 |
| Revvity, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 30, 2026 | K262893 | Eonis SMA kit Revvity, Inc. | QUE |
| Nov 9, 2022 | DEN200044 | Eonis SCID-SMA Kit Perkinelmer, Inc. | QUE |
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