BEUDAMED
    FDA Registration Active 🇺🇸 United States

    A1c-Cellular

    Reg #: 1950302 · FEI: 1950302 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    STRECK LLC
    Registration Number
    1950302
    FEI Number
    1950302
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    7002 SOUTH 109TH ST.
    City
    La Vista
    State
    NE
    ZIP
    68128
    Country
    US

    Regulatory Submissions

    510(k) Number
    K040025

    Owner / Operator

    Firm Name
    STRECK
    Operator Number
    1950302
    Address
    7002 SOUTH 109TH ST., --
    City
    La Vista
    State
    NE
    Postal Code
    68128
    Country
    US
    Correspondent
    Wendy - Royalty

    Products

    Device Name Product Code
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    A1c-Cellular A1c-Cellular Linearity

    Establishment Types

    Manufacture Medical Device