BEUDAMED
    FDA Registration Active 🇺🇸 United States

    60-PC0030 Pointe Phencyclidine Calibrator (100 ng/mL)

    Reg #: 1827821 · FEI: 1827821 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    24
    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
    K020769

    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
    Drug Specific Control Materials LAS

    Proprietary Names

    60-PC0030 Pointe Phencyclidine Calibrator (100 ng/mL) 60-CC0074 Pointe Cocaine Level 1 Control (BE 225 ng/mL) 60-PC0026 Pointe Phencyclidine Calibrator (25 ng/mL) 60-AM0088 Pointe Amphetamines 1000 Calibrator (MAMP 1500 ng/mL) 60-AM0084 Pointe Amphetamines 1000 Calibrator (MAMP 500 ng/mL) 60-CC0068 Pointe Cocaine Calibrator (BE 1000 ng/mL) 60-AM0094 Pointe Amphetamines 1000 Level 1 Control (MAMP 750 ng/mL) 60-PC0036 Pointe Phencyclidine Level 2 Control (32 ng/mL) 60-CC0076 Pointe Cocaine Level 2 Control (BE 375 ng/mL) 60-CC0066 Pointe Cocaine Calibrator (BE 300 ng/mL) 60-AM0096 Pointe Amphetamines 1000 Level 2 Control (MAMP 1250 ng/mL) 60-OP0046 Pointe Opiate Calibrator (Morphine 300 ng/mL) 60-PC0024 Pointe Phencyclidine Calibrator (12.5 ng/mL) 60-PC0034 Pointe Phencyclidine Level 1 Control (18 ng/mL) 60-OP0050 Pointe Opiate Calibrator (Morphine 1000 ng/mL) 60-CC0070 Pointe Cocaine Calibrator (BE 3000 ng/mL) 60-PC0028 Pointe Phencyclidine Calibrator (50 ng/mL) 60-OP0048 Pointe Opiate Calibrator (Morphine 600 ng/mL) 60-AM0086 Pointe Amphetamines 1000 Calibrator (MAMP 1000 ng/mL) 60-OP0044 Pointe Opiate Calibrator (Morphine 150 ng/mL) 60-OP0054 Pointe Opiate Level 1 Control (Morphine 225 ng/mL) 60-CC0064 Pointe Cocaine Calibrator (BE 150 ng/mL) 60-AM0090 Pointe Amphetamines 1000 Calibrator (MAMP 2000 ng/mL) 60-OP0056 Pointe Opiate Level 2 Control (Morphine 375 ng/mL)

    Establishment Types

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