BEUDAMED
    FDA Registration Active 🇺🇸 United States

    A1CNow Self Check

    Reg #: 2954361 · FEI: 3002940409 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    POLYMER TECHNOLOGY SYSTEMS, INC.
    Registration Number
    2954361
    FEI Number
    3002940409
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    510 Oakmead Pkwy
    City
    SUNNYVALE
    State
    CA
    ZIP
    94085
    Country
    US

    Regulatory Submissions

    510(k) Number
    K090413

    Owner / Operator

    Firm Name
    POLYMER TECHNOLOGY SYSTEMS, INC.
    Operator Number
    9031081
    Address
    4600 Anson Blvd.
    City
    Whitestown
    State
    IN
    Postal Code
    46075
    Country
    US

    Products

    Device Name Product Code
    Assay, Glycosylated Hemoglobin LCP

    Proprietary Names

    A1CNow Self Check Walgreens At-Home A1C Test Kit A1CNow+ Professional Use (A1CNow+ Monitor; A1CNow+ Test Cartridge; A1CNow+ Dilution Kit) A1CNow+ Professional Use ReliOn A1C Self-Test System CVS Health At Home A1C Test Kit True+ A1CNow Self Check

    Establishment Types

    Manufacture Medical Device