510(k) K932615 ยท LAO Enzyme Immunoassay, Methotrexate
TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Jul 14, 1993 |
| Received | Jun 1, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K932615
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2007 | Abbott Diagnostic International, Ltd. TDx/TDxFLx Methotrexate II Reagent-List Number 07A12-60 - a reagent system for In Vitro diagnostic use. This reagent system is composed of one bottle of Wash Solution, one bottle of Methotrexate Antib Terminated |
LAO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.