510(k) DEN180056 ยท QJE Muscular Dystrophy Newborn Screening Test
GSP Neonatal Creatine Kinase - MM kit
| Applicant | Perkinelmer, Inc., Waltham MA, US |
| Decision | Unknown, Dec 12, 2019 |
| Received | Oct 11, 2018 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN180056
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.