BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IR961-X Affirm 1 Multi Analyte Low Control

    Reg #: 3003593973 · FEI: 3003593973 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Infrared Laboratory Systems dba SYNERMED
    Registration Number
    3003593973
    FEI Number
    3003593973
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    17408 Tiller Ct Ste 1900
    City
    WESTFIELD
    State
    IN
    ZIP
    46074
    Country
    US

    Regulatory Submissions

    510(k) Number
    K940571

    Owner / Operator

    Firm Name
    Infrared Laboratory Systems, LLC
    Operator Number
    10038715
    Address
    17408 Tiller Court Suite 1900
    City
    Westfield
    State
    IN
    Postal Code
    46074
    Country
    US
    Correspondent
    Craig L Denney

    Products

    Device Name Product Code
    Calibrator, Multi-Analyte Mixture JIX

    Proprietary Names

    IR961-X Affirm 1 Multi Analyte Low Control IR954 Synermed IR Cal II Multi Analyte Calibrator IR962-X Affirm 2 Multi Analyte High Control

    Establishment Types

    Manufacture Medical Device