510(k) K262893 · QUE Spinal Muscular Atrophy Newborn Screening Test System
Eonis SMA kit
| Applicant | Revvity, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Sep 30, 2026 |
| Received | Aug 17, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K262893
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.