BEUDAMED
    FDA Registration Active 🇺🇸 United States

    60-AM0214 Pointe Amphetamines 500 Level 1 Control (MAMP 375 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
    K102210

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

    Proprietary Names

    60-AM0214 Pointe Amphetamines 500 Level 1 Control (MAMP 375 ng/mL) 60-AM0200 Pointe Amphetamines 500 Reagent 60-AM0216 Pointe Amphetamines 500 Level 2 Control (MAMP 625 ng/mL) 60-AM0208 Pointe Amphetamines 500 Calibrator (MAMP 1000 ng/mL) 60-AM0206 Pointe Amphetamines 500 Calibrator (MAMP 500 ng/mL) 60-AM0210 Pointe Amphetamines 500 Calibrator (MAMP 2000 ng/mL) 60-AM0204 Pointe Amphetamines 500 Calibrator (MAMP 250 ng/mL)

    Establishment Types

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