510(k) K953718 ยท KXT Enzyme Immunoassay, Digoxin
AXSYM DIGOXIN II
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Sep 25, 1995 |
| Received | Aug 9, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953718
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2008 | Abbott Diagnostic International, Ltd. AxSYM Digoxin II Reagent Pack, Disk Version 1. (3D53-01 or 3D53-02)
The AxSYM Digoxin II assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative measurement of digoxin, a cardiovascul Terminated |
KXT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.