510(k) K904329 ยท MCB Antigen, C. Difficile
CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY
| Applicant | Baxter Healthcare Corp, Bellevue WA, US |
| Decision | Substantially Equivalent, Mar 12, 1991 |
| Received | Sep 20, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904329
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.