510(k) K863485 ยท LLH Reagents, Clostridium Difficile Toxin
MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST
| Applicant | Marion Laboratories, Inc., Kansas City MI, US |
| Decision | Substantially Equivalent, Sep 17, 1986 |
| Received | Sep 9, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K863485
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.