510(k) K981743 ยท CKB Acid Phosphatase, Naphthyl Phosphate
OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER
| Applicant | Olympus America, Inc., Melville NY, US |
| Decision | Substantially Equivalent, Jun 9, 1998 |
| Received | May 18, 1998 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K981743
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2026 | Beckman Coulter Mishima K.K. Systems/units containing affected software/SQL
BECKMAN COULTER CHEMISTRY ANALYZER AU480
REF / UDI-DI code:
B96692 / 14987666542965
B96693 / 14987666542972
B12183 / 14987666540671
The AU480 Chemistry Open, Classified |
JJE | None listed |
| 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 |
CKB | 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.