510(k) K863842 ยท KLT Enzyme Immunoassay, Carbamazepine
SERALYZER ARIS CARBAMAZEPINE STRIPS/MODU/CALI/CONT
| Applicant | Miles Laboratories, Inc., Elkhart IN, US |
| Decision | Substantially Equivalent, Jan 14, 1987 |
| Received | Oct 1, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K863842
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.