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

• Cleared 510(k) Submissions with Supporting Documents
• Complete List of Substantially Equivalent 510(k) Device Applications
• 510(k) Blood Establishment Computer Software

Related Information

• Premarket Notification 510(k) Process for CBER-Regulated Products
• Evaluation of Automatic Class III Designation (De Novo) Summaries (CBER)

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