BEUDAMED
    FDA Registration Active 🇺🇸 United States

    True Focus Pro

    Reg #: 1219029 · FEI: 1219029 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    5
    Classifications
    3

    Registration Details

    Registration Name
    NOVA BIOMEDICAL CORPORATION
    Registration Number
    1219029
    FEI Number
    1219029
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    200 Prospect St
    City
    WALTHAM
    State
    MA
    ZIP
    02454
    Country
    US

    Regulatory Submissions

    510(k) Number
    K131013

    Owner / Operator

    Firm Name
    NOVA BIOMEDICAL CORP.
    Operator Number
    1219029
    Address
    200 PROSPECT ST., --
    City
    Waltham
    State
    MA
    Postal Code
    02454
    Country
    US
    Correspondent
    John F McHale

    Products

    Device Name Product Code
    Glucose Dehydrogenase, Glucose LFR
    System, Test, Blood Glucose, Over The Counter NBW
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    True Focus Pro Focus Pro Focus

    Establishment Types

    Manufacture Device in the United States for Export Only Complaint File Establishment per 21 CFR 820.198 Remanufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device