510(k) K934003 ยท DKA Antiserum, Digoxin
STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY
| Applicant | Baxter Diagnostics, Inc., Mcgaw Park IL, US |
| Decision | Substantially Equivalent, Nov 22, 1994 |
| Received | Aug 17, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934003
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.