U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

  1. Home
  2. Vaccines, Blood & Biologics
  3. Blood & Blood Products
  4. Approved Blood Products
  5. Substantially Equivalent 510(k) Device Information
  6. Cleared 510(k) Submissions with Supporting Documents
  1. Substantially Equivalent 510(k) Device Information

Cleared 510(k) Submissions with Supporting Documents

Back to Top