510(k) K871645 ยท DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
TDXR REA(TM) ETHANOL
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Jun 11, 1987 |
| Received | Apr 28, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K871645
| 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 |
| Feb 4, 2004 | Abbott Laboratories HPD/ADD/GPRD TDx/TDxFLx REA Ethanol, list 9545-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 Terminated |
DIC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.