BEUDAMED
    FDA Registration Active 🇺🇸 United States

    YSI INCORPORATED

    Reg #: 1550101 · FEI: 1550101 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    YSI INCORPORATED
    Registration Number
    1550101
    FEI Number
    1550101
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1700 Brannum Ln, 1725 Brannum Ln
    City
    Yellow Spgs
    State
    OH
    ZIP
    45387
    Country
    US

    Regulatory Submissions

    510(k) Number
    K210933

    Owner / Operator

    Firm Name
    YSI INCORPORATED
    Operator Number
    1550101
    Address
    1700 BRANNUM LN., --
    City
    Yellow Springs
    State
    OH
    Postal Code
    45387
    Country
    US
    Correspondent
    ERIC LUTE

    Products

    Device Name Product Code
    Acid, Lactic, Enzymatic Method KHP
    Analyzer, Enzyme, For Clinical Use JJI
    Glucose Oxidase, Glucose CGA

    Proprietary Names

    2900C BIOCHEMISTRY ANALYZER 2324C GLUCOSE STARTER KIT PLUS 2325C LACTATE STARTER KIT PLUS 2323C GLUCOSE/LACTATE KIT PLUS YSI 2900C BIOCHEMISTRY ANALYZER

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device