U.S. flag An official website of the United States government
  1. Home
  2. Vaccines, Blood & Biologics
  3. Blood & Blood Products
  4. Approved Blood Products
  5. Substantially Equivalent 510(k) Device Information
  6. BK080057 - MyCells Autologous Platelet Preparation Kit
  1. Substantially Equivalent 510(k) Device Information

BK080057 - MyCells Autologous Platelet Preparation Kit

510(k) Number: BK080057
Applicant: Kaylight Corporation
Device Name: MyCells Autologous Platelet Preparation Kit
Decision Date: 9/24/2009

Supporting Documents

  • BK080057 Letter
    The original SE letter has been replaced with a revised SE letter to revise the product code.
 
Back to Top