BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    GSP Neonatal Creatine Kinase-MM kit (3311-001U)

    Reg #: 8043909 · FEI: 3002808498 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    WALLAC OY
    Registration Number
    8043909
    FEI Number
    3002808498
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    MUSTIONKATU 6
    City
    TURKU Varsinais-Suomi
    Country
    FI

    Regulatory Submissions

    510(k) Number
    DEN180056

    Owner / Operator

    Firm Name
    Revvity, Inc.
    Operator Number
    9912035
    Address
    77 4th Avenue
    City
    Waltham
    State
    MA
    Postal Code
    02451
    Country
    US

    US Agent

    Business Name
    Revvity, Inc.
    Contact Name
    Daniel Castellanos
    Address
    77 4th Avenue
    City
    Waltham
    State
    MA
    ZIP
    02451
    Country
    US
    Email
    [email protected]
    Phone
    973 5808347

    Products

    Device Name Product Code
    Muscular Dystrophy Newborn Screening Test QJE

    Proprietary Names

    GSP Neonatal Creatine Kinase-MM kit (3311-001U)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device