510(k) K041003 ยท LLH Reagents, Clostridium Difficile Toxin
IMMUNOCARD TOXINS A & B, MODEL 712050
| Applicant | Meridian Bioscience, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Aug 20, 2004 |
| Received | Apr 19, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041003
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 4, 2006 | Meridian Bioscience Inc ImmunoCard toxins A & B kit, a rapid enzyme immunoassay for the detection of Clostridium difficile Toxins A and B in Stool Samples (Catalog number 712050). An in vitro diagnostic. Terminated |
LLH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.