510(k) K080635 ยท DKZ Enzyme Immunoassay, Amphetamine
MEDTOXSCAN
| Applicant | Medtox Diagnostics, Inc., Burlington NC, US |
| Decision | Substantially Equivalent, Feb 13, 2009 |
| Received | Mar 6, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080635
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2013 | Medtox Diagnostics Inc PROFILE-V MEDTOXScan Drugs of Abuse Test System.
For the rapid, qualitative detection of drugs of abuse in human urine, Terminated |
DIO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.