BEUDAMED
    FDA Registration Active 🇺🇸 United States

    85047 - WQC

    Reg #: 1217183 · FEI: 1217183 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    1

    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
    K992531

    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
    System, Automated Platelet Aggregation JOZ

    Proprietary Names

    85047 - WQC 70068 - EQC 85063 - Validation Kit 86000RF - VerifyNow Instrument 86000 - VerifyNow Instrument 86003 - VerifyNow Instrument 86003L - VerifyNow Instrument 86000D - VerifyNow Instrument 85062 - Preventative Maintenance Kit 86000L - VerifyNow Instrument 86003D - VerifyNow Instrument

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198