BEUDAMED
    FDA Registration Active 🇺🇸 United States

    60-EC0334 Pointe Ecstasy (MDMA) Control (375 ng/mL) Level 1

    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
    K033094

    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 Specific Control Materials LAS
    Enzyme Immunoassay, Amphetamine DKZ
    Calibrators, Drug Specific DLJ

    Proprietary Names

    60-EC0334 Pointe Ecstasy (MDMA) Control (375 ng/mL) Level 1 60-EC0320 Pointe Ecstasy (MDMA) Reagent 60-EC0326 Pointe Ecstasy (MDMA) Calibrator (500 ng/mL) Cutoff 60-EC0336 Pointe Ecstasy (MDMA) Control (625 ng/mL) Level 2 60-EC0324 Pointe Ecstasy (MDMA) Calibrator (100 ng/mL) Low 60-EC0328 Pointe Ecstasy (MDMA) Calibrator (750 ng/mL) Intermediate 60-EC0330 Pointe Ecstasy (MDMA) Calibrator (1000 ng/mL) High

    Establishment Types

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