510(k) K913562 ยท LCS Radioimmunoassay, Digoxin (125-I)
QMS - DIGOXIN
| Applicant | Seradyn, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 30, 1991 |
| Received | Aug 9, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913562
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.