510(k) K063845 ยท JFM Enzymatic Method, Bilirubin
ADVIA CHEMISTRY TOTAL BILIRUBIN_2
| Applicant | Bayer Healthcare, LLC, Tarrytown NY, US |
| Decision | Substantially Equivalent, Dec 7, 2007 |
| Received | Dec 27, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063845
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.