BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FreezePoint® Calibration Standard, 300 mOsmol/kg, 10x0.8mL

    Reg #: 1717966 · FEI: 1717966 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ELITechGroup Inc
    Registration Number
    1717966
    FEI Number
    1717966
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    370 West 1700 South
    City
    LOGAN
    State
    UT
    ZIP
    84321
    Country
    US

    Regulatory Submissions

    510(k) Number
    K032608

    Owner / Operator

    Firm Name
    ELITechGroup Inc.
    Operator Number
    1717966
    Address
    370 West 1700 South
    City
    Logan
    State
    UT
    Postal Code
    84321
    Country
    US

    Products

    Device Name Product Code
    Calibrator, Primary JIS

    Proprietary Names

    FreezePoint® Calibration Standard, 300 mOsmol/kg, 10x0.8mL FreezePoint® Calibration Standard, 850 mOsmol/kg, 10x0.8mL

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device