510(k) K203035 ยท PJI Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System
Eonis SCID-SMA kit
| Applicant | Perkinelmer, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Nov 9, 2022 |
| Received | Oct 5, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203035
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.