510(k) K131284 ยท NAK System, Test, Biotinidase
GSP NEONATAL BIOTINIDASE KIT
| Applicant | Wallac OY, Waltham MA, US |
| Decision | Substantially Equivalent, Nov 14, 2013 |
| Received | May 6, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131284
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.