BEUDAMED
    FDA Registration Active 🇺🇸 United States

    60-CC0696 Pointe Cocaine Metabolite 150 Level 2 Control (BE 187.5 ng/mL)

    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
    K113139

    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, Cocaine And Cocaine Metabolites DIO
    Drug Specific Control Materials LAS
    Calibrators, Drug Specific DLJ

    Proprietary Names

    60-CC0696 Pointe Cocaine Metabolite 150 Level 2 Control (BE 187.5 ng/mL) 60-CC0690 Pointe Cocaine Metabolite 150 Calibrator (BE 1000 ng/mL) 60-CC0688 Pointe Cocaine Metabolite 150 Calibrator (BE 300 ng/mL) 60-CC0680 Pointe Cocaine Metabolite 150 Reagent 60-CC0694 Pointe Cocaine Metabolite 150 Level 1 Control (BE 112.5 ng/mL) 60-CC0684 Pointe Cocaine Metabolite 150 Calibrator (BE 75 ng/mL) 60-CC0686 Pointe Cocaine Metabolite 150 Calibrator (BE 150 ng/mL)

    Establishment Types

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