BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    TEG 6s

    Reg #: 8020030 · FEI: 3006461677 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    LEICA BIOSYSTEMS MELBOURNE PTY LTD
    Registration Number
    8020030
    FEI Number
    3006461677
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    495 BLACKBURN RD., MOUNT WAVERLEY
    City
    MELBOURNE Victoria
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K183160

    Owner / Operator

    Firm Name
    Leica Biosystems, division of Leica Microsystems, Inc.
    Operator Number
    10054155
    Address
    21440 W. Lake Cook Road, Floor 5
    City
    Deer Park
    State
    IL
    Postal Code
    60010
    Country
    US
    Correspondent
    Adam Blunier

    US Agent

    Business Name
    Leica Biosystems, division of Leica Microsystems, Inc.
    Contact Name
    Adam Blunier
    Address
    21440 W. Lake Cook Road, Floor 5
    City
    Deer Park
    State
    IL
    ZIP
    60010
    Country
    US
    Email
    [email protected]
    Phone
    630 6340069 ext. 3462

    Products

    Device Name Product Code
    System, Multipurpose For In Vitro Coagulation Studies JPA

    Proprietary Names

    TEG 6s

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)