BEUDAMED
    2 results · 18ms · Sources: EU EUDAMED, US FDA

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    ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.

    FDA Enforcement
    Class II ·Ongoing·BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.·March 5, 2025