BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GH100 - GEM Hemochron 100 System

    Reg #: 1217183 · FEI: 1217183 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    INSTRUMENTATION LABORATORY CO.
    Registration Number
    1217183
    FEI Number
    1217183
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    180 Hartwell Rd.
    City
    Bedford
    State
    MA
    ZIP
    01730
    Country
    US

    Regulatory Submissions

    510(k) Number
    K202101

    Owner / Operator

    Firm Name
    Instrumentation Laboratory Co.
    Operator Number
    1217183
    Address
    180 Hartwell Road, --
    City
    Bedford
    State
    MA
    Postal Code
    01730
    Country
    US
    Correspondent
    Carol - Marble

    Products

    Device Name Product Code
    Activated Whole Blood Clotting Time JBP
    System, Multipurpose For In Vitro Coagulation Studies JPA
    Plasma, Coagulation Control GGN

    Proprietary Names

    GH100 - GEM Hemochron 100 System GH100L - GEM Hemochron 100 System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198