510(k) K032897 ยท LLH Reagents, Clostridium Difficile Toxin
C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96
| Applicant | Ivd Research, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, May 27, 2004 |
| Received | Sep 17, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032897
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.