BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    T-TAS 01 Total Thrombus Formation Analysis System Instrument

    Reg #: 3017875469 · FEI: 3017875469 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    ZACROS CORPORATION
    Registration Number
    3017875469
    FEI Number
    3017875469
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1-1-1 KOISHIKAWA, BUNKYO-KU, BUNKYO GARDEN GATE TOWER 22F
    City
    Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K191364

    Owner / Operator

    Firm Name
    ZACROS CORPORATION
    Operator Number
    10062628
    Address
    1-1-1 Koishikawa, Bunkyo-ku
    City
    Tokyo
    State
    JP-13
    Postal Code
    112-0002
    Country
    JP

    US Agent

    Business Name
    Hikari Dx, Inc.
    Contact Name
    Jeffrey Dahlen
    Address
    11435 Merritage Court
    City
    San Diego
    State
    CA
    ZIP
    92131
    Country
    US
    Email
    [email protected]
    Phone
    619 7420203

    Products

    Device Name Product Code
    System, Automated Platelet Aggregation JOZ

    Proprietary Names

    T-TAS 01 Total Thrombus Formation Analysis System Instrument PL Chip Reservoir Set for T-TAS 01 BAPA Tube for T-TAS 01 PL Chip for T-TAS 01 PL Chip Reservoir set PL Chip BAPA tube

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device