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
- 510k Blood Establishment Computer Software
Related Information
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Contact Point
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3103
Silver Spring, MD 20993-0002
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3103
Silver Spring, MD 20993-0002
(800) 835-4709
(240) 402-8010
Hours Available
Food and Drug Administration
Food and Drug Administration
White Oak Campus
White Oak Campus
10903 New Hampshire Ave
Silver Spring, MD 20993
United States
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The latest information from the Center for Biologics Evaluation and Research.