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510(k) Data Aggregation

    K Number
    K970100
    Device Name
    TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL
    Manufacturer
    SIMPLICITY DIAGNOSTICS, INC.
    Date Cleared
    1997-03-10

    (59 days)

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

    SIMPLICITY DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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