BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Home Access A1C Test

    Reg #: 1423455 · FEI: 3000206414 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    HOME ACCESS HEALTH CORP.
    Registration Number
    1423455
    FEI Number
    3000206414
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2401 Hassell Rd Ste 1510
    City
    Hoffman Est
    State
    IL
    ZIP
    60169
    Country
    US

    Regulatory Submissions

    510(k) Number
    K141944

    Owner / Operator

    Firm Name
    PWNHealth Chicago, LLC
    Operator Number
    9031348
    Address
    2401 W. HASSELL RD., SUITE 1510
    City
    Hoffman Estates
    State
    IL
    Postal Code
    60169
    Country
    US
    Correspondent
    nikolas isely

    Products

    Device Name Product Code
    Assay, Glycosylated Hemoglobin LCP
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA

    Proprietary Names

    Home Access A1C Test

    Establishment Types

    Manufacture Medical Device