510(k) K082638 ยท KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL
| Applicant | Siemens Healthcare Diagnostics, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Feb 26, 2009 |
| Received | Sep 10, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082638
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2018 | Siemens Healthcare Diagnostics, Inc. STREAMLAB CORE UNIT / LYNX WITH IOM Terminated |
LXG | None listed |
| Aug 14, 2018 | Siemens Healthcare Diagnostics, Inc. STREAMLAB - REFRIGERATED STORAGE MODULE 9000 Terminated |
LXG | None listed |
| Aug 14, 2018 | Siemens Healthcare Diagnostics, Inc. STREAMLAB - REFRIGERATED STORAGE MODULE 15000 Terminated |
LXG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.