510(k) K042808 ยท KLT Enzyme Immunoassay, Carbamazepine
ADVIA IMS CARBAMAZEPINE METHOD
| Applicant | Bayer Healthcare, LLC, Tarrytown NY, US |
| Decision | Substantially Equivalent, Feb 8, 2005 |
| Received | Oct 12, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042808
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.