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    FDA Registration Active 🇺🇸 United States

    60-OP0674 Pointe Opiate 2000 Level 1 Control (Morphine 1500 ng/mL)

    Reg #: 1827821 · FEI: 1827821 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    HORIBA INSTRUMENTS INCORPORATED
    Registration Number
    1827821
    FEI Number
    1827821
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5449 RESEARCH DRIVE
    City
    Canton Twp
    State
    MI
    ZIP
    48188
    Country
    US

    Regulatory Submissions

    510(k) Number
    K120761

    Owner / Operator

    Firm Name
    HORIBA INSTRUMENTS INCORPORATED (DBA) HORIBA Medical
    Operator Number
    10083022
    Address
    9755 Research Drive
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US

    Products

    Device Name Product Code
    Enzyme Immunoassay, Opiates DJG
    Drug Specific Control Materials LAS
    Calibrators, Drug Specific DLJ

    Proprietary Names

    60-OP0674 Pointe Opiate 2000 Level 1 Control (Morphine 1500 ng/mL) 60-OP0664 Pointe Opiate 2000 Calibrator (Morphine 1000 ng/mL) 60-OP0676 Pointe Opiate 2000 Level 2 Control (Morphine 2500 ng/mL) 60-OP0670 Pointe Opiate 2000 Calibrator (Morphine 6000 ng/mL) 60-OP0666 Pointe Opiate 2000 Calibrator (Morphine 2000 ng/mL) 60-OP0660 Pointe Opiate 2000 Reagent 60-OP0668 Pointe Opiate 2000 Calibrator (Morphine 4000 ng/mL)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device