510(k) K993914 ยท LLH Reagents, Clostridium Difficile Toxin
PREMIER TOXINS A&B, MODEL 616096
| Applicant | Meridian Diagnostics, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Dec 10, 1999 |
| Received | Nov 17, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K993914
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2003 | Meridian Bioscience Inc Premier Toxins A & B, Diagnostic Test Kits, Catalog No. 616096. Terminated |
LLH | None listed |
| Jan 23, 2003 | Meridian Bioscience Inc Premier brand Toxins A & B, diagnostic 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.