Substantially Equivalent 510(k) Device Information
The following products are regulated as 510(k)s: Devices used by the blood banking industry including blood establishment computer software, transfer devices, collection systems, separators, culture bottles, fluid warmers, etc.
List of 510(k) submissions
Information is arranged in alphabetical order by the name of the applicant.
510(k) Process (CBER)
Development and Approval Process information