BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ELITE - Hemochron ELITE Instrument

    Reg #: 3002721930 · FEI: 2250033 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Accriva Diagnostics, Inc.
    Registration Number
    3002721930
    FEI Number
    2250033
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6260 Sequence Drive
    City
    San Diego
    State
    CA
    ZIP
    92121
    Country
    US

    Regulatory Submissions

    510(k) Number
    K050016

    Owner / Operator

    Firm Name
    Accriva Diagnostics, Inc.
    Operator Number
    10048042
    Address
    6260 Sequence Drive
    City
    San Diego
    State
    CA
    Postal Code
    92121
    Country
    US
    Correspondent
    Paula Morgan

    Products

    Device Name Product Code
    System, Multipurpose For In Vitro Coagulation Studies JPA

    Proprietary Names

    ELITE - Hemochron ELITE Instrument ELITEL - Hemochron ELITE Instrument RPM-CD - Report Maker V61 ELITERF - Hemochron ELITE Instrument ELITEDEMO - Hemochron ELITE Instrument

    Establishment Types

    Manufacture Medical Device