510(k) K801084 ยท LCQ Fluorescent Immunoassay Gentamicin
CYBREX GENTAMICIN
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, May 23, 1980 |
| Received | May 7, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801084
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 26, 2008 | Abbott Diagnostic International, Ltd. Abbott TDx/TDxFLx Gentamicin Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of gentamicin flourescein tracer and Terminated |
LCQ | None listed |
| Feb 26, 2008 | Abbott Diagnostic International, Ltd. Abbott TDx/TDxFLx Gentamicin Wedge Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of gentamicin flourescein trac Terminated |
LCQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.