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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.

U.S. Food and Drug Administration
  1. Home
  2. Vaccines, Blood & Biologics
  3. Blood & Blood Products
  4. Approved Blood Products
  5. Substantially Equivalent 510(k) Device Information
  6. BK220722 - Smart Kit Basic, Smart Kit Pro
  1. Substantially Equivalent 510(k) Device Information
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