BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SURE-TECH DIAGNOSTIC ASSOCIATES, INC.

    Reg #: 1938095 · FEI: 1938095 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SURE-TECH DIAGNOSTIC ASSOCIATES, INC.
    Registration Number
    1938095
    FEI Number
    1938095
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    12115 Tesson Ferry Professional Ctr
    City
    Saint Louis
    State
    MO
    ZIP
    63128
    Country
    US

    Regulatory Submissions

    510(k) Number
    K892241

    Owner / Operator

    Firm Name
    SURE-TECH DIAGNOSTIC ASSOCIATES, INC.
    Operator Number
    1938095
    Address
    12115 Tesson Ferry Professional Center, --
    City
    Saint Louis
    State
    MO
    Postal Code
    63128
    Country
    US
    Correspondent
    Thomas Buck

    Products

    Device Name Product Code
    Stain, Fetal Hemoglobin GHQ
    Mixture, Hematology Quality Control JPK

    Proprietary Names

    KLEIHAUER-BETKE KIT FETAL HEMOGLOBIN KIT Fetal Hemoglobin Control

    Establishment Types

    Manufacture Medical Device