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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