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510(k) Data Aggregation

    K Number
    K041871
    Device Name
    INTERLAB MICROCAL SERUM CONTROLS
    Manufacturer
    TROUBLE SHOOTER CONSULING, INC.
    Date Cleared
    2004-08-16

    (38 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    TROUBLE SHOOTER CONSULING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microcal Normal and Abnormal Controls are lyophilized human sera intended for use as assayed quality control sera to monitor the precision of cellulose acetate based protein electrophoresis testing methods.
    Device Description
    lyophilized human sera intended for use as assayed quality control sera
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