BEUDAMED
    FDA Registration Active 🇺🇸 United States

    60-HY0788 Pointe Hydrocodone 300 Calibrator (500 ng/mL)

    Reg #: 1827821 · FEI: 1827821 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    14
    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
    K141055

    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
    Calibrators, Drug Specific DLJ
    Enzyme Immunoassay, Opiates DJG

    Proprietary Names

    60-HY0788 Pointe Hydrocodone 300 Calibrator (500 ng/mL) 60-HY0784 Pointe Hydrocodone 300 Calibrator (150 ng/mL) 60-HY0764 Pointe Hydrocodone 100 Calibrator (50 ng/mL) 60-HY0780 Pointe Hydrocodone 300 Reagent 60-HY0774 Pointe Hydrocodone 100 Level 1 Control (75 ng/mL) 60-HY0796 Pointe Hydrocodone 300 Level 2 Control (375 ng/mL) 60-H70776 Pointe Hydrocodone 100 Level 2 Control (125 ng/mL) 60-HY0790 Pointe Hydrocodone 300 Calibrator (800 ng/mL) 60-HY0794 Pointe Hydrocodone 300 Level 1 Control (225 ng/mL) 60-HY0766 Pointe Hydrocodone 100 Calibrator (100 ng/mL) 60-HY0760 Pointe Hydrocodone 100 Reagent 60-HY0770 Pointe Hydrocodone 100 Calibrator (300 ng/mL) 60-HY0768 Pointe Hydrocodone 100 Calibrator (150 ng/mL) 60-HY0786 Pointe Hydrocodone 300 Calibrator (300 ng/mL)

    Establishment Types

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