510(k) K840826 ยท DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
TDX ETHANOL
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Apr 13, 1984 |
| Received | Feb 24, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K840826
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD Package Insert for TDx/TDxFLx and TDxFLx Gentamicin Reagents, REF 9512, item numbers 34-1074/R3 and 69-5120/R2; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 Terminated |
LCD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.