BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Hematachek

    Reg #: 2248933 · FEI: 3000206772 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    RICHMOND DIAGNOSTICS, INC.
    Registration Number
    2248933
    FEI Number
    3000206772
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    525 Milltown Road, Suite 403-404
    City
    North Brunswick
    State
    NJ
    ZIP
    08902
    Country
    US

    Regulatory Submissions

    510(k) Number
    K964452

    Owner / Operator

    Firm Name
    RICHMOND DIAGNOSTICS, INC.
    Operator Number
    9028307
    Address
    525 Milltown Road, Suite 403-404
    City
    North Brunswick
    State
    NJ
    Postal Code
    08902
    Country
    US
    Correspondent
    DAVID J SHICK

    Products

    Device Name Product Code
    Control, Hematocrit GLK

    Proprietary Names

    Hematachek

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)