BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GEM Premier 7000 with iQM3 PAK

    Reg #: 1217183 · FEI: 1217183 · Expires 2025
    View on FDA
    Products
    12
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    12

    Registration Details

    Registration Name
    INSTRUMENTATION LABORATORY CO.
    Registration Number
    1217183
    FEI Number
    1217183
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    180 Hartwell Rd.
    City
    Bedford
    State
    MA
    ZIP
    01730
    Country
    US

    Regulatory Submissions

    510(k) Number
    K223608

    Owner / Operator

    Firm Name
    Instrumentation Laboratory Co.
    Operator Number
    1217183
    Address
    180 Hartwell Road, --
    City
    Bedford
    State
    MA
    Postal Code
    01730
    Country
    US
    Correspondent
    Carol - Marble

    Products

    Device Name Product Code
    Acid, Lactic, Enzymatic Method KHP
    Glucose Oxidase, Glucose CGA
    Bilirubin (Total And Unbound) In The Neonate Test System MQM
    System, Hemoglobin, Automated GKR
    Electrode, Ion-Specific, Chloride CGZ
    Electrode, Ion Specific, Potassium CEM
    Assay, Carboxyhemoglobin GHS
    Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph CHL
    Instrument, Hematocrit, Automated GKF
    Electrode, Ion Specific, Calcium JFP
    Oximeter To Measure Hemoglobin GLY
    Electrode, Ion Specific, Sodium JGS

    Proprietary Names

    GEM Premier 7000 with iQM3 PAK GEM Premier 7000 with iQM3

    Establishment Types

    Manufacture Medical Device