BEUDAMED
    FDA Registration Active 🇺🇸 United States

    60-ME0236 Pointe Methadone Level 2 Control (375 ng/mL)

    Reg #: 1827821 · FEI: 1827821 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    12
    Establishment Types
    2
    Classifications
    2

    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
    K023316

    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

    Proprietary Names

    60-ME0236 Pointe Methadone Level 2 Control (375 ng/mL) 60-PP0254 Pointe Propoxyphene Control (225 ng/mL) Level 1 60-PP0250 Pointe Propoxyphene Calibrator (1000 ng/mL) High 60-ME0224 Pointe Methadone Calibrator (150 ng/mL) 60-PP0256 Pointe Propoxyphene Control (375 ng/mL) Level 2 60-ME0234 Pointe Methadone Level 1 Control (225 ng/mL) 60-PP0246 Pointe Propoxyphene Calibrator (300 ng/mL) Cutoff 60-PP0248 Pointe Propoxyphene Calibrator (600 ng/mL) Intermediate 60-ME0230 Pointe Methadone Calibrator (1000 ng/mL) 60-PP0244 Pointe Propoxyphene Calibrator (150 ng/mL) Low 60-ME0228 Pointe Methadone Calibrator (600 ng/mL) 60-ME0226 Pointe Methadone Calibrator (300 ng/mL)

    Establishment Types

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