BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Corning Incorporated Discovery Labware

    Reg #: 1054657 · FEI: 1000110807 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    24
    Establishment Types
    3
    Classifications
    7

    Registration Details

    Registration Name
    Corning Incorporated Discovery Labware
    Registration Number
    1054657
    FEI Number
    1000110807
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1 BECTON CIR
    City
    Durham
    State
    NC
    ZIP
    27712
    Country
    US

    Regulatory Submissions

    510(k) Number
    K991253

    Owner / Operator

    Firm Name
    Corning Incorporated
    Operator Number
    1317452
    Address
    836 North Street, Building 300
    City
    Tewksbury
    State
    MA
    Postal Code
    01876
    Country
    US
    Correspondent
    Amber Aagaard

    Products

    Device Name Product Code
    Labware, Assisted Reproduction MQK
    Spinner, Flask KJD
    Dish, Tissue Culture KIZ
    Flask, Tissue Culture KJA
    Bottle, Roller, Tissue Culture KJC
    Labware, Assisted Reproduction, Exempt PUD
    Container, Specimen, Sterile FMH

    Proprietary Names

    Falcon IVF Dishes and Plates Falcon In Vitro Fertilization (IVF) Plasticware Corning Spinner Flasks and accessories, various styles and sizes Tissue Culture Dish and BioAssay Dish Custom Transwell Permeable Supports > 100 cm2; PureCoat Cell Culture Plates and Dishes, various Styles and Sizes Primaria flasks greater than 100 square cm surface area. PureCoat Flasks various sizes. Falcon, Costar and Corning CELLBIND cell culture flasks greater than 100 square cm surface area Synthemax Flasks sizes greater than 100 square cm surface area Falcon MultiFlasks, various styles greater than 100 square cm surface area Corning Erlenmeyer Flasks, various sizes; Corning PureCoat rLaminin-521 Cultureware; various sizes HYPERFlasks and HYPERStack vessels and accessories; various styles and sizes CellCube Systems and accessories, various styles and sizes CellSTACK Culture Chambers and accesories, various styles and sizes PureCoat Flasks various sizes Corning and Custom roller bottles and accessories Corning CellBIND roller bottles and accessories; Corning Easy Grip Storage Bottle and accessories Falcon In Vitro Fertilization 4 Well Dish Falcon IVF Plates and Dishes Corning Closed Systems individually wrapped centrifuge tubes and accessories Falcon Individually Wrapped Round-Bottom Tubes; Corning Cryogenic vials and accessories; Containers

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Sterilize Medical Device for Another Party (Contract Sterilizer) Manufacture Medical Device