BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Bialex Enzymatic Cholesterol Oxidase

    Reg #: 3021841051 · FEI: 3021841051 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BIALEX LAB
    Registration Number
    3021841051
    FEI Number
    3021841051
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    717 Ohio Ave
    City
    Wichita Falls
    State
    TX
    ZIP
    76301
    Country
    US

    Regulatory Submissions

    510(k) Number
    K870928

    Owner / Operator

    Firm Name
    Bialex Lab
    Operator Number
    10049801
    Address
    717 Ohio Ave
    City
    Wichita Falls
    State
    TX
    Postal Code
    76301
    Country
    US
    Correspondent
    Carlos H Quine

    Products

    Device Name Product Code
    Enzymatic Esterase--Oxidase, Cholesterol CHH

    Proprietary Names

    Bialex Enzymatic Cholesterol Oxidase

    Establishment Types

    Manufacture Medical Device