BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GH100 - GEM Hemochron 100 System

    Reg #: 3002721930 · FEI: 2250033 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    3

    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
    K202101

    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
    Activated Whole Blood Clotting Time JBP
    Plasma, Coagulation Control GGN

    Proprietary Names

    GH100 - GEM Hemochron 100 System GH100L - GEM Hemochron 100 System

    Establishment Types

    Manufacture Medical Device