BEUDAMED
    FDA Registration Active 🇺🇸 United States

    60-MM0390 Pointe Methadone Metabolite (EDDP) Calibrator (1000 ng/mL) High

    Reg #: 1827821 · FEI: 1827821 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    9
    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
    K031797

    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, Methadone DJR
    Calibrators, Drug Specific DLJ

    Proprietary Names

    60-MM0390 Pointe Methadone Metabolite (EDDP) Calibrator (1000 ng/mL) High 60-MM0404 Pointe Methadone Metabolite (EDDP) Calibrator (50 ng/mL) Low 60-MM0384 Pointe Methadone Metabolite (EDDP) Calibrator (150 ng/mL) Low 60-MM0406 Pointe Methadone Metabolite (EDDP) Calibrator (100 ng/mL) Cutoff 60-MM0410 Pointe Methadone Metabolite (EDDP) Calibrator (500 ng/mL) High 60-MM0386 Pointe Methadone Metabolite (EDDP) Calibrator (300 ng/mL) Cutoff 60-MM0380 Pointe Methadone Metabolite (EDDP) Reagent 60-MM0408 Pointe Methadone Metabolite (EDDP) Calibrator (250 ng/mL) Intermediate 60-MM0388 Pointe Methadone Metabolite (EDDP) Calibrator (600 ng/mL) Intermediate

    Establishment Types

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