BEUDAMED
    FDA Registration Active 🇺🇸 United States

    60-OX0494 Pointe Oxycodone Control (375 ng/mL)

    Reg #: 1827821 · FEI: 1827821 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    10
    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
    K120763

    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
    Drug Specific Control Materials LAS
    Enzyme Immunoassay, Opiates DJG
    Calibrators, Drug Specific DLJ

    Proprietary Names

    60-OX0494 Pointe Oxycodone Control (375 ng/mL) 60-OX0484 Pointe Oxycodone Control (75 ng/mL) 60-OX0488 Pointe Oxycodone Control (125 ng/mL) 60-OX0490 Pointe Oxycodone Control (225 ng/mL) 60-OX0492 Pointe Oxycodone Calibrator (300 ng/mL) 60-OX0486 Pointe Oxycodone Calibrator (100 ng/mL) 60-OX0496 Pointe Oxycodone Calibrator (500 ng/mL) 60-OX0498 Pointe Oxycodone Calibrator (800 ng/mL) 60-OX0480 Pointe Oxycodone Reagent 60-OX0504 Pointe Oxycodone Calibrator (50 ng/mL)

    Establishment Types

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