510(k) K980185 ยท LLH Reagents, Clostridium Difficile Toxin
COLORPAC TOXIN A
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic, Sparks MD, US |
| Decision | Substantially Equivalent, Jul 17, 1998 |
| Received | Jan 20, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980185
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.