510(k) K011720 ยท CIX Bromcresol Green Dye-Binding, Albumin
OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER
| Applicant | Olympus America, Inc., Irving TX, US |
| Decision | Substantially Equivalent, Jun 25, 2001 |
| Received | Jun 4, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011720
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 5, 2013 | Beckman Coulter Inc. ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer.
Automated chemistry analyzers that measures analytes in samples. Terminated |
JJE | None listed |
| May 29, 2013 | Beckman Coulter Inc. AU2700 Clinical Chemistry Analyzer
AU5400 Clinical Chemistry Analyzer
Perform automated analysis of serum, urine, and other body fluids, including whole blood. Terminated |
JJE | None listed |
| Feb 7, 2012 | Beckman Coulter Inc. AU Clinical Chemistry Analyzers: Model Number:
AU400 Clinical Chemistry Analyzer,
AU400(e) Clinical Chemistry Analyzer,
AU480 Clinical Chemistry Analyzer.
The AU Clinical Chemistry Analyzers are ful Terminated |
JJE | None listed |
| Feb 7, 2012 | Beckman Coulter Inc. AU Clinical Chemistry Analyzers: Model Number:
AU5400 Clinical Chemistry Analyzer.
The AU Clinical Chemistry Analyzers are fully automated photometric analyzers intended for clinical laboratory use Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.