BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OneDraw A1C Test System

    Reg #: 3015798231 · FEI: 3015798231 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    DRAWBRIDGE HEALTH, INC.
    Registration Number
    3015798231
    FEI Number
    3015798231
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    620 Omni Industrial Blvd
    City
    Summerville
    State
    SC
    ZIP
    29486
    Country
    US

    Regulatory Submissions

    510(k) Number
    K183230

    Owner / Operator

    Firm Name
    Drawbridge Health, Inc.
    Operator Number
    10062165
    Address
    152 W 57th Street, 44th Floor
    City
    New York
    State
    NY
    Postal Code
    10019
    Country
    US
    Correspondent
    Ron Cain

    Products

    Device Name Product Code
    Assay, Glycosylated Hemoglobin LCP
    Capillary Blood Collection Device For Alternative Site Collection PRJ

    Proprietary Names

    OneDraw A1C Test System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device