510(k) K033479 ยท LLH Reagents, Clostridium Difficile Toxin
PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY
| Applicant | Remel, Inc., Ramsey MN, US |
| Decision | Substantially Equivalent, Feb 26, 2004 |
| Received | Nov 3, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033479
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.