510(k) K884528 ยท KXT Enzyme Immunoassay, Digoxin
SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES
| Applicant | Heraeus Kulzer, Inc., Elkhart IN, US |
| Decision | Substantially Equivalent, Mar 8, 1989 |
| Received | Oct 28, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884528
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.