510(k) K090123 ยท NAK System, Test, Biotinidase
NEONATAL BIOTINIDASE KIT, MODEL 3018
| Applicant | Perkinelmer, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Mar 5, 2010 |
| Received | Jan 21, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090123
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.