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510(k) Data Aggregation

    K Number
    K011169
    Device Name
    HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3
    Manufacturer
    INTERNATIONAL ENZYMES, INC.
    Date Cleared
    2001-05-18

    (31 days)

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

    INTERNATIONAL ENZYMES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K963085
    Device Name
    LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III
    Manufacturer
    INTERNATIONAL ENZYMES, INC.
    Date Cleared
    1996-08-20

    (12 days)

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

    INTERNATIONAL ENZYMES, INC.

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

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