BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Quantisal

    Reg #: 3008264082 · FEI: 3008264082 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    STATSURE DIAGNOSTIC SYSTEMS
    Registration Number
    3008264082
    FEI Number
    3008264082
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1337 E 9TH ST
    City
    Brooklyn
    State
    NY
    ZIP
    11230
    Country
    US

    Regulatory Submissions

    510(k) Number
    K942435

    Owner / Operator

    Firm Name
    StatSure Diagnostic Systems
    Operator Number
    10053144
    Address
    1337 East 9 Street
    City
    Brooklyn
    State
    NY
    Postal Code
    11230
    Country
    US
    Correspondent
    Mo Bodner

    Products

    Device Name Product Code
    Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device PJD

    Proprietary Names

    Quantisal Saliva Sampler

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility