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510(k) Data Aggregation

    K Number
    K973457
    Device Name
    CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800
    Manufacturer
    SHARED SYSTEMS, INC.
    Date Cleared
    1998-01-02

    (112 days)

    Product Code
    GMZ
    Regulation Number
    866.3255
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHARED SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The E. coli 0157 Latex Agglutination Test is a rapid test for E. coli serogroup 0157 detection in all primary cultures suspected to be E. coli spp.
    Device Description
    Not Found
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