BEUDAMED
    FDA Registration Active 🇺🇸 United States

    KSL Biomedical, Inc.

    Reg #: 3017505309 · FEI: 3017505309 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    KSL Biomedical, Inc.
    Registration Number
    3017505309
    FEI Number
    3017505309
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    55 Amherst Villa Road
    City
    Buffalo
    State
    NY
    ZIP
    14225
    Country
    US

    Regulatory Submissions

    510(k) Number
    K923771

    Owner / Operator

    Firm Name
    KSL Diagnostics Inc.
    Operator Number
    10075006
    Address
    55 Amherst Villa Road
    City
    Cheektowaga
    State
    NY
    Postal Code
    14225
    Country
    US
    Correspondent
    Beverly Sobilo

    Products

    Device Name Product Code
    System, Test, Rheumatoid Factor DHR
    C-Reactive Protein, Antigen, Antiserum, And Control DCK
    Antigens, Nontreponemal, All GMQ

    Proprietary Names

    Rheumatoid Factor (RF) Latex Test C-Reactive Protein (CRP) Latex Test RPR Carbon Antigen

    Establishment Types

    Manufacture Medical Device