510(k) K935376 ยท LCD Enzyme Immunoassay, Gentamicin
AXSYM GENTAMICIN
| Applicant | Abbott Mfg., Inc., Abbott Park IL, US |
| Decision | Substantially Equivalent, Jun 21, 1994 |
| Received | Nov 8, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935376
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 26, 2008 | Abbott Diagnostic International, Ltd. Abbott AxSYM Gentamicin Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of pretreatment solution and one bottle o Terminated |
LCD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.