BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AdaptDx, AdaptDx Pro

    Reg #: 3016500342 · FEI: 3016500342 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    LumiThera Diagnostics, Inc
    Registration Number
    3016500342
    FEI Number
    3016500342
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1000 Kreider Drive, STE 700
    City
    Middletown
    State
    PA
    ZIP
    17057
    Country
    US

    Regulatory Submissions

    510(k) Number
    K100954

    Owner / Operator

    Firm Name
    LumiThera, Inc.
    Operator Number
    10085722
    Address
    19578 10th Avenue NE, Suite 200
    City
    Poulsbo
    State
    WA
    Postal Code
    98370
    Country
    US

    Products

    Device Name Product Code
    Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation OUM

    Proprietary Names

    AdaptDx, AdaptDx Pro

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device