Wellkang® LLC
  • Introduction

  • List of Official Steps:
    1. Log-in Procedures
    2. Division Acceptance Criteria
    3. Reviewer Assignment
    4. FDA Requests for
      Additional Information

    5. Administrative Review
    6. Decision Letter Issued
  • 510(k) Status Program

    February 11, 2002:

    The FDA requires that all non-US medical device manufacturers wishing to market their products in the United States must have a local representative in the US, i.e. the “US Agent”.

    Wellkang LLC is your reliable “US Agent” in dealing with FDA.



      510(k) Status Program:

    Applicants may request information on their 510(k) review status 90 days after the initial log-in date of the 510(k). Thereafter, the applicant may request status reports by submitting a Status Request Form to the CDRH. The CDRH will send the applicant a fax or letter that includes:
    • The ODE division or branch to which the 510(k) is assigned;
    • The last action, and date of action, that ODE has taken regarding the 510(k);
    • The position of the 510(k) in the reviewer's queue; and
    • The average review time for the division or branch.

    Click here to learn more...

    | Home | Services | Our Clients | About Us | Online Shop | Contact Us | Partners & Links |

    Copyright© 2004 - 2006 Wellkang® LLC - Member of Wellkang® Group
    All Rights Reserved. Terms of Use, Copyright& Disclaimer.
    Some information at this site is obtained from websites & publications of FDA
    Last updated on
    Melbourne, Florida, USA