510(k) K884968 ยท DJR Enzyme Immunoassay, Methadone
TDX METHADONE ASSAY
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Dec 16, 1988 |
| Received | Nov 30, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884968
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 4, 2004 | Abbott Laboratories HPD/ADD/GPRD TDx/TDxFLx Methadone, list 9676-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 Terminated |
DJR | None listed |
| Feb 4, 2004 | Abbott Laboratories HPD/ADD/GPRD ADx Methadone, list 9676-55; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 Terminated |
DJR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.