510(k) K112412 ยท CEM Electrode, Ion Specific, Potassium
AU5800(R) CHEMISTRY ANALYZER
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Dec 23, 2011 |
| Received | Aug 22, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112412
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 3, 2017 | Beckman Coulter Inc. Beckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack ID Labels)
The Beckman Coulter AU680 and the AU5800 Clinical Chemistry Analyzers are an automated chemistry analyzer that m Terminated |
JJE | None listed |
| Aug 1, 2016 | Beckman Coulter Inc. AU5800 Chemistry Analyzers, Reference No. A98352
The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appr Terminated |
JJE | None listed |
| Nov 5, 2013 | Beckman Coulter Inc. ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 Chemistry Analyzer.
Automated chemistry analyzers that measures analytes in samples. Terminated |
JJE | None listed |
| Aug 2, 2013 | Beckman Coulter Inc. Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers.
An automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quali Terminated |
JJE | None listed |
| Jul 31, 2013 | Beckman Coulter Inc. AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers AU5811, AU5821, AU5831 and AU5841. This system is for in vitro diagnostic use only. Terminated |
JJE | None listed |
| Apr 24, 2013 | Beckman Coulter Inc. AU5800 Clinical Chemistry Analyzer
The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagent Terminated |
JJE | None listed |
| Mar 6, 2013 | Beckman Coulter Inc. Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium. Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.