BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CLINICAL DIAGNOSTIC SOLUTIONS, INC.

    Reg #: 1064130 · FEI: 3002684533 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    0
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    CLINICAL DIAGNOSTIC SOLUTIONS, INC.
    Registration Number
    1064130
    FEI Number
    3002684533
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1800 N.W. 65TH AVE.
    City
    PLANTATION
    State
    FL
    ZIP
    33313
    Country
    US

    Regulatory Submissions

    510(k) Number
    K041130

    Owner / Operator

    Firm Name
    Boule Diagnostics AB
    Operator Number
    9034165
    Address
    Domnarvsgatan 4
    City
    Spanga
    State
    SE-NOTA
    Postal Code
    SE-163 53
    Country
    SE

    Products

    Device Name Product Code
    Calibrator For Hemoglobin And Hematocrit Measurement KRZ
    Calibrator For Platelet Counting KRY
    Calibrator For Red-Cell And White-Cell Counting KSA

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device