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    FDA Registration Active 🇺🇸 United States

    60-AC0598 Pointe 6-Acetylmorphine Calibrator (0 ng/mL) Negative

    Reg #: 1827821 · FEI: 1827821 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    8
    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
    K101195

    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
    Enzyme Immunoassay, Opiates DJG
    Drug Specific Control Materials LAS

    Proprietary Names

    60-AC0598 Pointe 6-Acetylmorphine Calibrator (0 ng/mL) Negative 60-AC0588 Pointe 6-Acetylmorphine Calibrator (20 ng/mL) Intermediate 60-AC0584 Pointe 6-Acetylmorphine Calibrator (5 ng/mL) Low 60-AC0580 Pointe 6-Acetylmorphine Reagent 60-AC0596 Pointe 6-Acetylmorphine Control (12.5 ng/mL) Level 2 60-AC0594 Pointe 6-Acetylmorphine Control (7.5 ng/mL) Level 1 60-AC0590 Pointe 6-Acetylmorphine Calibrator (40 ng/mL) High 60-AC0586 Pointe 6-Acetylmorphine Calibrator (10 ng/mL) Cutoff

    Establishment Types

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