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    K Number
    K191552
    Device Name
    GM501 Mineral Oil
    Manufacturer
    Hamilton Thorne Inc.
    Date Cleared
    2019-09-18

    (98 days)

    Product Code
    MQLMOL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hamilton Thorne Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    GM501 Mineral Oil is intended for use as an overlay for culture of gametes, zygotes, or embryos in Assisted Reproduction Technology (ART) and micro-manipulation procedures.
    Device Description
    GM501 Mineral Oil is light, mineral oil (paraffin oil) which is used to overlay cell culture media during Assisted Reproductive Technology (ART) or In Vitro Fertilization (IVF) procedures. The oil overlay is intended to protect the culture medium from evaporation in the incubator, limiting potential temperature, osmolality and pH changes in the medium. GM501 Mineral Oil is aseptically filtered and provided in bottles of 100 ml and 500 ml. This product has an 18-month shelf-life when stored as recommended.
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