BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HDL Direct Reagent and Calibrator

    Reg #: 2085064 · FEI: 1000135102 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    CLINIQA CORPORATION
    Registration Number
    2085064
    FEI Number
    1000135102
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    495 Enterprise Street
    City
    San Marcos
    State
    CA
    ZIP
    92078
    Country
    US

    Regulatory Submissions

    510(k) Number
    K982767

    Owner / Operator

    Firm Name
    CLINIQA CORPORATION
    Operator Number
    2083131
    Address
    495 Enterprise Street, --
    City
    San Marcos
    State
    CA
    Postal Code
    92078
    Country
    US
    Correspondent
    Dawn - Gast

    Products

    Device Name Product Code
    Calibrator, Multi-Analyte Mixture JIX
    Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl LBS

    Proprietary Names

    HDL Direct Reagent and Calibrator

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device