BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Clarity Rapid Strep A test

    Reg #: 3004043187 · FEI: 3004043187 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Clarity Diagnostics, LLC
    Registration Number
    3004043187
    FEI Number
    3004043187
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1060 Holland Dr STE A
    City
    BOCA RATON
    State
    FL
    ZIP
    33487
    Country
    US

    Regulatory Submissions

    510(k) Number
    K023766

    Owner / Operator

    Firm Name
    33487
    Operator Number
    9057600
    Address
    1060 Holland Dr STE A, --
    City
    Boca Raton
    State
    FL
    Postal Code
    33487
    Country
    US
    Correspondent
    Richard - Simpson

    Products

    Device Name Product Code
    Antigens, All Groups, Streptococcus Spp. GTY

    Proprietary Names

    Clarity Rapid Strep A test

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198