510(k) K953115 ยท DKZ Enzyme Immunoassay, Amphetamine
AXSYM AMPHETAMINE/METHAMPHETAMINE II
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Oct 6, 1995 |
| Received | Jul 3, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953115
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 14, 2008 | Abbott Laboratories AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0; List Number: 3D54-08; Abbott La boratories, Diagnostics Division, Abbott Park, IL 60064 Terminated |
DKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.