510(k) K961274 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER
| Applicant | Olympus America, Inc., Melville NY, US |
| Decision | Substantially Equivalent, Jul 5, 1996 |
| Received | Apr 2, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961274
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 4, 2025 | Beckman Coulter Mishima K.K. Sample probe sucks a sample dispensed into a tube or cup and discharges the
appropriate amount into a cuvette.
Lot 178713114 - 179433670 Completed |
JJE | None listed |
| 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. AU680 Chemistry Analyzers, Reference No. B04779
The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appro Terminated |
JJE | None listed |
| 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 |
| 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 |
| 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:
AU600 Clinical Chemistry Analyzer,
AU640 Clinical Chemistry Analyzer,
AU640(e) Clinical Chemistry Analyzer,
AU680 Clinical Chemistry Analyzer.
The AU Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.