510(k) DEN150035 ยท PQW Alpha-D-Galactosidase A (Gla) Newborn Screening Test System
SEEKER System
| Applicant | Baebies, Inc., Durham NC, US |
| Decision | Unknown, Feb 3, 2017 |
| Received | Aug 5, 2015 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN150035
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.