510(k) K000903 ยท KLT Enzyme Immunoassay, Carbamazepine
ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, May 18, 2000 |
| Received | Mar 21, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000903
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.