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510(k) Data Aggregation

    K Number
    K994361
    Device Name
    ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL
    Manufacturer
    GENESIS INDUSTRIES, INC.
    Date Cleared
    2000-02-18

    (53 days)

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

    GENESIS INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ESP Tissue Culture Plates are single-use labware intended for use in cell culturing and diagnostic laboratory procedures.
    Device Description
    The polystyrene ESP tissue culture plates consist of a square base plate with a square lid key wayed to interlock with the base plate. The key way system keeps the lid securely on the base plate. The bottom of the base plate is recessed to allow stacking of multiple plates without the plates sliding apart. The ability to stack plates reduces space requirements during storage and incubation. The 7 cm x 7 cm square shape allows for handling ease regardless of hand size. ESP plates are sterilized using gamma irradiation. Five configurations of ESP tissue culture plates are available. All five types of plates are identical except for the different physical configurations described below. ESP Four Well Tissue Culture Plate: Four equally spaced wells with rounded bottoms. Each well is 3 cm in diameter and has a 5 milliliter capacity. The wells are numbered clockwise, with the numbers molded into each plate. ESP Six Well Tissue Culture Plate: Six equally spaced wells in a circular configuration. Each well is 2 cm in diameter and has a rounded bottom with a 2.5 milliliter capacity. The wells are numbered counterclockwise, with the numbers molded into each plate. ESP Micro Six Well Tissue Culture Plate: Six equally spaced wells in a circular configuration. Each well is 2 cm in diameter and has a rounded bottom with a 1milliliter capacity. The wells are numbered counterclockwise, with the numbers molded into each plate. ESP Well in Well Tissue Culture Plate: A small well (2 cm diameter) within a large well (5.5 cm diameter). The two wells are separated by a vertical wall and a flat ledge. ESP Square Tissue Culture Plate with Grid: A flat surface marked with a square grid consisting of 25 one-half inch squares. The squares are numbered 1 - 5 across the top, and A - E down the left side. The markings are molded into the bottom side of the base, leaving a smooth working surface on the top side of the base.
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    K Number
    K962828
    Device Name
    EVERT-IT
    Manufacturer
    GENESIS INDUSTRIES, INC.
    Date Cleared
    1997-02-10

    (206 days)

    Product Code
    HGY
    Regulation Number
    884.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENESIS INDUSTRIES, INC.

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