510(k) K061249 ยท KXT Enzyme Immunoassay, Digoxin
AXSYM DIGOXIN III
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Jun 2, 2006 |
| Received | May 4, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061249
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2007 | Abbott Diagnostic International, Ltd. Abbott Diagnostic International, Ltd.-- AxSYM Digoxin III Reagent Pack, List (6L07-20), For In Vitro Diagnostic use. This reagent system is composed of one bottle of Digoxin-Alkaline Phosphatase Conj Terminated |
KXT | None listed |
| Aug 29, 2007 | Abbott Diagnostic International, Ltd. Abbott AxSYM System Digoxin III Reagent Pack Terminated |
KXT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.