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510(k) Data Aggregation

    K Number
    K973973
    Device Name
    ELECSYS CALLCHECK DIGOXIN
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Date Cleared
    1997-11-04

    (15 days)

    Product Code
    DMP
    Regulation Number
    862.3280
    Why did this record match?
    Product Code :

    DMP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Boehringer Mannheim Elecsys CalCheck DIGOXIN is used to verify the calibration assignment for the Boehringer Mannheim Elecsys DIGOXIN assay. Elecsys® CalCheck™ DIGOXIN calibration verification solutions comprise three levels - low, mid, and high - each with a defined DIGOXIN concentration. The low solution concentration is near the lower detection limit of the assay. The mid solution is in the middle or at the clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range. The Elecsys® CalCheck™ DIGOXIN is intended for use in periodic verification of the calibration of the Elecsys® DIGOXIN reagent.
    Device Description
    The Elecsys® CalCheck™ DIGOXIN is a three level single analyte set of stable liquid, bovine based materials. They are assayed in triplicate and the results compared to the target values.
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