510(k) K833070 ยท LER Fluorescent Immunoassay, Theophylline
TDX THEOPHYLLINE
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Nov 14, 1983 |
| Received | Sep 8, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K833070
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 3, 2007 | Abbott Diagnostic International, Ltd. IMx Theophylline Reagent Pack (List 1A81-20) In Vitro test.
This reagent system is composed of one bottle of Theophylline Pretreatment Solution, one bottle of Theophylline Antiserum (Mouse Monoclonal) Terminated |
LER | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.