BEUDAMED
    FDA Registration Active 🇭🇺 Hungary

    HEMATOLOGY ANALYZER

    Reg #: 3006198300 · FEI: 3006198300 · Expires 2025
    View on FDA
    Products
    12
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    12

    Registration Details

    Registration Name
    Diamond Diagnostics Inc.
    Registration Number
    3006198300
    FEI Number
    3006198300
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6 Oradna Street
    City
    Budapest
    Country
    HU

    Regulatory Submissions

    510(k) Number
    K061974

    Owner / Operator

    Firm Name
    Diamond Diagnostics Inc.
    Operator Number
    10028706
    Address
    333 Fiske St
    City
    Holliston
    State
    MA
    Postal Code
    01746
    Country
    US
    Correspondent
    Kathy Fisher

    US Agent

    Business Name
    DIAMOND DIAGNOSTICS INC.
    Contact Name
    Kathy Fisher
    Address
    333 Fiske St
    City
    Holliston
    State
    MA
    ZIP
    01746
    Country
    US
    Email
    [email protected]
    Phone
    508 4290450 ext. 358

    Products

    Device Name Product Code
    Assay, Carboxyhemoglobin GHS
    Control, Hematocrit GLK
    Electrode, Ion-Specific, Chloride CGZ
    Acid, Lactic, Enzymatic Method KHP
    Instrument, Hematocrit, Automated GKF
    Electrode, Ion Specific, Sodium JGS
    System, Hemoglobin, Automated GKR
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Electrode, Ion Specific, Calcium JFP
    Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph CHL
    Glucose Oxidase, Glucose CGA
    Electrode, Ion Specific, Potassium CEM

    Proprietary Names

    HEMATOLOGY ANALYZER

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device