510(k) K011920 ยท KXT Enzyme Immunoassay, Digoxin
EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229
| Applicant | Syva Co., Dade Behring, Inc., Cupertino CA, US |
| Decision | Substantially Equivalent, Jul 2, 2001 |
| Received | Jun 20, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011920
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.