510(k) DEN990008 ยท NAK System, Test, Biotinidase
WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000
| Applicant | Wallac, Inc., Norton OH, US |
| Decision | Unknown, Feb 15, 2000 |
| Received | Dec 20, 1999 |
| Type | Post-NSE |
| FDA record | Open on fda.gov |
Recalls that name DEN990008
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.