BEUDAMED
    FDA Registration Active 🇺🇸 United States

    60-MP0700 Pointe Methamphetamine Reagent

    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
    K113661

    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
    Calibrators, Drug Specific DLJ
    Drug Specific Control Materials LAS
    Gas Chromatography, Methamphetamine LAF

    Proprietary Names

    60-MP0700 Pointe Methamphetamine Reagent 60-MP0710 Pointe Methamphetamine Calibrator (2000 ng/mL) High 60-MP0716 Pointe Methamphetamine Control (625 ng/mL) Level 2 60-MP0704 Pointe Methamphetamine Calibrator (250 ng/mL) Low 60-MP0706 Pointe Methamphetamine Calibrator (500 ng/mL) Cutoff 60-MP0708 Pointe Methamphetamine Calibrator (1000 ng/mL) Intermediate 60-MP0714 Pointe Methamphetamine Control (375 ng/mL) Level 1

    Establishment Types

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