BEUDAMED
    FDA Registration Active 🇺🇸 United States

    UTAK LABORATORIES, INC.

    Reg #: 2022375 · FEI: 2022375 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    22
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    UTAK LABORATORIES, INC.
    Registration Number
    2022375
    FEI Number
    2022375
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    25020 AVENUE TIBBITTS
    City
    VALENCIA
    State
    CA
    ZIP
    91355
    Country
    US

    Regulatory Submissions

    510(k) Number
    K800883

    Owner / Operator

    Firm Name
    UTAK LABORATORIES, I
    Operator Number
    2022375
    Address
    25020 AVENUE TIBBITTS, --
    City
    Valencia
    State
    CA
    Postal Code
    91355
    Country
    US
    Correspondent
    Kevin M Kopp

    Products

    Device Name Product Code
    Drug Mixture Control Materials DIF
    Drug Specific Control Materials LAS
    Multi-Analyte Controls, All Kinds (Assayed) JJY

    Proprietary Names

    Cardiacs I Control Amoxapine Control Cardiacs II Control Hypnotics + Salicylate Control Tricyclic Antidepressants Control Maprotiline Control UTAK STABBS Control Trace Elements Control Clonazepam Control Disopyramide Control Whole Blood Lead Controls UTAK Toxicology Control Benzodiazepines Control TRICYLIC ANTIDEPRESSANTS Li Tx Control Caffeine Control TRICYLIC ANTIDEPRESSANTS Vi Pentobarbital Control Anticonvulsants Control Hypnotics + Acetaminophen Control Vancomycin Control Barbiturates Control Flurazepam Control

    Establishment Types

    Manufacture Medical Device