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    FDA Registration Active 🇺🇸 United States

    EARLITEC DIAGNOSTICS

    Reg #: 3027553518 · FEI: 3027553518 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

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    Registration Details

    Registration Name
    EARLITEC DIAGNOSTICS
    Registration Number
    3027553518
    FEI Number
    3027553518
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    13895 Industrial Park Blvd Ste 140
    City
    Plymouth
    State
    MN
    ZIP
    55441
    Country
    US

    Regulatory Submissions

    510(k) Number
    K230337

    Owner / Operator

    Firm Name
    EarliTec Diagnostics
    Operator Number
    10088360
    Address
    13895 Industrial Park Blvd, Suite 140
    City
    Plymouth
    State
    MN
    Postal Code
    55441
    Country
    US
    Correspondent
    Ryan Bormann

    Products

    Device Name Product Code
    Pediatric Autism Spectrum Disorder Diagnosis Aid QPF

    Proprietary Names

    EarliPoint

    Establishment Types

    Manufacture Medical Device