BEUDAMED
    FDA Registration Active 🇺🇸 United States

    LensHooke Semen Test Cassette

    Reg #: 1221433 · FEI: 1221433 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    HAMILTON THORNE, Inc.
    Registration Number
    1221433
    FEI Number
    1221433
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    100 CUMMINGS CENTER-SUITE 465E
    City
    Beverly
    State
    MA
    ZIP
    01915
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180343

    Owner / Operator

    Firm Name
    Hamilton Thorne, Inc.
    Operator Number
    1221433
    Address
    100 Cummings Center, Suite 465E
    City
    Beverly
    State
    MA
    Postal Code
    01915
    Country
    US
    Correspondent
    Nicole M Thibodeau

    Products

    Device Name Product Code
    Semen Analysis Device POV
    Counter, Differential Cell GKZ

    Proprietary Names

    LensHooke Semen Test Cassette LensHooke X1 Pro Semen Quality Analyzer LensHooke Semen Quality Analyzer LensHooke C-KUP Liquefaction Test Cup LensHooke Liquefaction Test Cup LensHooke X1 Semen Quality Analyzer

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198