BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FETAL HEMOGLOBIN KIT

    Reg #: 1938095 · FEI: 1938095 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SURE-TECH DIAGNOSTIC ASSOCIATES, INC.
    Registration Number
    1938095
    FEI Number
    1938095
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    11040 LIN VALLE DR., SUITE D
    City
    Affton
    State
    MO
    ZIP
    63123
    Country
    US

    Regulatory Submissions

    510(k) Number
    K892241

    Owner / Operator

    Firm Name
    SURE-TECH DIAGNOSTIC ASSOCIATES, INC.
    Operator Number
    1938095
    Address
    11040 LIN VALLE DR., SUITE D, --
    City
    Saint Louis
    State
    MO
    Postal Code
    63123
    Country
    US
    Correspondent
    Thomas Buck

    Products

    Device Name Product Code
    Stain, Fetal Hemoglobin GHQ

    Proprietary Names

    FETAL HEMOGLOBIN KIT KLEIHAUER-BETKE KIT

    Establishment Types

    Manufacture Medical Device