BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PATHFAST cTnI-II

    Reg #: 2435505 · FEI: 1000119795 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC.
    Registration Number
    2435505
    FEI Number
    1000119795
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    510 FURNACE DOCK RD.
    City
    CORTLANDT MANOR
    State
    NY
    ZIP
    10567
    Country
    US

    Regulatory Submissions

    510(k) Number
    K100130

    Owner / Operator

    Firm Name
    POLYMEDCO, INC.
    Operator Number
    9001475
    Address
    510 FURNACE DOCK RD., --
    City
    Cortlandt Manor
    State
    NY
    Postal Code
    10567
    Country
    US
    Correspondent
    Todd - Kelley

    Products

    Device Name Product Code
    Immunoassay Method, Troponin Subunit MMI
    Calibrator, Secondary JIT

    Proprietary Names

    PATHFAST cTnI-II

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198