BEUDAMED
    FDA Registration Active 🇺🇸 United States

    60-MA1716 Pointe Multi-Analyte Set C Urine DAU Level 2 Control

    Reg #: 1827821 · FEI: 1827821 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    7
    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
    K133710

    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 Mixture Control Materials DIF
    Calibrators, Drug Mixture DKB

    Proprietary Names

    60-MA1716 Pointe Multi-Analyte Set C Urine DAU Level 2 Control 60-MA1706 Pointe Multi-Analyte Set C Urine DAU Cutoff Calibrator 60-UN0002 Pointe Universal Negative Calibrator 60-MA1714 Pointe Multi-Analyte Set C Urine DAU Level 1 Control 60-MA1710 Pointe Multi-Analyte Set C Urine DAU High Calibrator 60-MA1704 Pointe Multi-Analyte Set C Urine Low Calibrator 60-MA1708 Pointe Multi-Analyte Set C Urine DAU Intermediate Calibrator

    Establishment Types

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