510(k) DEN200044 ยท QUE Spinal Muscular Atrophy Newborn Screening Test System
Eonis SCID-SMA Kit
| Applicant | Perkinelmer, Inc., Waltham MA, US |
| Decision | Unknown, Nov 9, 2022 |
| Received | Jul 8, 2020 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN200044
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.