6 results
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28ms
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Sources: EU EUDAMED, US FDA
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Country: Japan
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Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
FDA Enforcement
Class II
·Completed·Beckman Coulter Mishima K.K.·June 11, 2025
CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Mishima K.K.·March 18, 2026
DxC 700 AU, REF: B86444, B86446
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Mishima K.K.·March 18, 2026
DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Mishima K.K.·August 7, 2024
DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Mishima K.K.·August 28, 2024
Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
FDA Enforcement
Class II
·Completed·Beckman Coulter Mishima K.K.·June 11, 2025