510(k) K011648 ยท KLT Enzyme Immunoassay, Carbamazepine
RANDOX CARBAMAZEPINE
| Applicant | Randox Laboratories, Ltd., Crumlin, GB |
| Decision | Substantially Equivalent, Jan 15, 2002 |
| Received | May 29, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011648
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.