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510(k) Data Aggregation

    K Number
    K980638
    Device Name
    ADI SYPHILIS RPR LIQUID CONTROLS
    Manufacturer
    AMPCOR DIAGNOSTICS, INC.
    Date Cleared
    1998-07-06

    (137 days)

    Product Code
    GMP
    Regulation Number
    866.3820
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMPCOR DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ampcor RPR control kit is designed as an unassayed control material to monitor the precision of AMPCOR RPR (Carbon-Particle) Liquid Reagent or other RPR tests at three reaction levels.
    Device Description
    Not Found
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