510(k) K041951 ยท LLH Reagents, Clostridium Difficile Toxin
XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B
| Applicant | Remel, Inc., Lenexa KS, US |
| Decision | Substantially Equivalent, Nov 15, 2004 |
| Received | Jul 20, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041951
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.