510(k) K190266 ยท PQW Alpha-D-Galactosidase A (Gla) Newborn Screening Test System
NeoLSD MSMS Kit
| Applicant | Perkinelmer, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, May 3, 2019 |
| Received | Feb 8, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190266
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.