510(k) K926442 ยท LLH Reagents, Clostridium Difficile Toxin
PREMIER C. DIFFICILE, MODIFICATION
| Applicant | Meridian Diagnostics, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Jan 27, 1993 |
| Received | Dec 16, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K926442
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 23, 2003 | Meridian Bioscience Inc Premier brand C. difficile Toxin A, diagnstic test kits, one kit per pouch, one pouch per shipping box. Terminated |
MCB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.