Substantially Equivalent 510(k) Device Information

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

• 510(k) Process (CBER)
  Development and Approval Process information

• Resources for You:
  • Consumers (Biologics)
  • Healthcare Providers (Biologics)
  • Industry (Biologics)
  • About the Center for Biologics Evaluation and Research (CBER)
• Recalls & Alerts:
  • Recalls (Biologics)
  • CBER-Regulated Products: Shortages and Discontinuations
  • Report a Problem to the Center for Biologics Evaluation & Research
• Approvals & Clearances:
  • Biologics Products & Establishments

Follow CBER

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

ocod@fda.hhs.gov

(800) 835-4709

(240) 402-8010

Food and Drug Administration

Food and Drug Administration
White Oak Campus

10903 New Hampshire Ave

Silver Spring, MD 20993
United States

For Updates on Twitter follow

@fdacber

The latest information from the Center for Biologics Evaluation and Research.