Vaccines, Blood & Biologics
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Platelet PGD Test System (2009)
Applicant: Verax Biomedical Incorporated, Worcester, MA
510(k) number: BK090028
Product: Platelet PGD Test System
Date: 11/10/2009
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BK090028 Letter BK090028 Summary (PDF - 35KB)BK090028 Package Insert (PDF - 500KB)FDA Clears First Rapid Test for Bacterial Contamination in Pooled Platelets
FDA Press Release, November 13, 2009
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Contact FDA
(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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