510(k) K974881 ยท MCB Antigen, C. Difficile
TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A
| Applicant | Biosite Incorporated, San Diego CA, US |
| Decision | Substantially Equivalent, Mar 20, 1998 |
| Received | Dec 30, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974881
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 27, 2008 | Biosite Inc Triage Micro ClostrIdium difficile (C.difficile) Panel, Catalog No: 96000, BIOSITE INCORPORATED, San Diego, CA 92121 Terminated |
MCB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.