510(k) K173829 ยท PQW Alpha-D-Galactosidase A (Gla) Newborn Screening Test System
NeoLSD MSMS kit
| Applicant | Wallac Oy, A Subsidiary of Perkinelmer, Waltham MA, US |
| Decision | Substantially Equivalent, Jul 18, 2018 |
| Received | Dec 18, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173829
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.