510(k) K854542 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
TDX C-REACTIVE PROTEIN
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Jan 24, 1986 |
| Received | Nov 13, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854542
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 4, 2004 | Abbott Laboratories HPD/ADD/GPRD TDx/TDxFLx C-Reactive Protein (CRP) Reagents, list 9550-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 Terminated |
DCK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.