510(k) K915602 ยท KXT Enzyme Immunoassay, Digoxin
SRI DIGOXIN ENZYME IMMUNOASSAY
| Applicant | Serono-Baker Diagnostics, Inc., Allentown PA, US |
| Decision | Substantially Equivalent, Jan 17, 1992 |
| Received | Dec 13, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915602
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.