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510(k) Data Aggregation

    K Number
    K081896
    Device Name
    BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH
    Manufacturer
    Date Cleared
    2008-08-20

    (48 days)

    Product Code
    Regulation Number
    884.6160
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOGENICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The plate is a sterile non-pyrogenic, Embryotoxicity tested single use plasticware intended for preparing, storing, manipulating or transferring human gametes or incended for proparing, (IVF), or other in vitro fertilization techniques or cell culture.
    Device Description
    Biogenics BioQuad™ 4-Well IVF Culture Dish
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