510(k) K880823 ยท KXT Enzyme Immunoassay, Digoxin
AMERLITE DIGOXIN ASSAY, LAN.0700/2700, 240/144 KIT
| Applicant | Amersham Corp., Arlington Heights IL, US |
| Decision | Substantially Equivalent, May 31, 1988 |
| Received | Mar 1, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K880823
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.