BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CK/LD Isoenzyme Control

    Reg #: 1825740 · FEI: 1825740 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Analytical Control Systems
    Registration Number
    1825740
    FEI Number
    1825740
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9058 Technology Drive
    City
    Fishers
    State
    IN
    ZIP
    46038
    Country
    US

    Regulatory Submissions

    510(k) Number
    K800370

    Owner / Operator

    Firm Name
    ANALYTICAL CONTROL SYSTEMS
    Operator Number
    1825740
    Address
    9058 TECHNOLOGY DR., --
    City
    Fishers
    State
    IN
    Postal Code
    46038
    Country
    US
    Correspondent
    Eric A BONDERMAN

    Products

    Device Name Product Code
    Multi-Analyte Controls, All Kinds (Assayed) JJY

    Proprietary Names

    CK/LD Isoenzyme Control SC-103

    Establishment Types

    Manufacture Medical Device