BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MyCare Psychiatry Clozapine Assay Kit

    Reg #: 3005567065 · FEI: 3005567065 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SALADAX BIOMEDICAL, INC.
    Registration Number
    3005567065
    FEI Number
    3005567065
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    116 RESEARCH DR.
    City
    BETHLEHEM
    State
    PA
    ZIP
    18015
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN190028

    Owner / Operator

    Firm Name
    SALADAX BIOMEDICAL, INC.
    Operator Number
    9097239
    Address
    116 RESEARCH DR., --
    City
    Bethlehem
    State
    PA
    Postal Code
    18015
    Country
    US
    Correspondent
    Salvatore Salamone, PhD

    Products

    Device Name Product Code
    Clozapine Test System QKT

    Proprietary Names

    MyCare Psychiatry Clozapine Assay Kit

    Establishment Types

    Manufacture Medical Device