BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HemaPrompt

    Reg #: 1123776 · FEI: 1000219815 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    AERSCHER DIAGNOSTICS
    Registration Number
    1123776
    FEI Number
    1000219815
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    125 Dixon Drive
    City
    CHESTERTOWN
    State
    MD
    ZIP
    21620
    Country
    US

    Regulatory Submissions

    510(k) Number
    K972763

    Owner / Operator

    Firm Name
    AERSCHER DIAGNOSTICS
    Operator Number
    9007799
    Address
    125 Dixon Drive, --
    City
    Chestertown
    State
    MD
    Postal Code
    21620
    Country
    US
    Correspondent
    ROBERT - SCHREIBER

    Products

    Device Name Product Code
    Reagent, Occult Blood KHE

    Proprietary Names

    HemaPrompt

    Establishment Types

    Manufacture Medical Device