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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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DACS SC (Buoyant Density Solution 60)

Product: DACS SC (Buoyant Density Solution 60)
Applicant: Dendreon Corp., Seattle, WA
PMA number: BP970003
Indication for Use: Processing autologous mobilized peripheral blood progenitor cells (PBPC) collected by leukapheresis to reduce RBC, platelets and granulocytes in the final PBPC product.
Approval Date: 7/23/99

Letter

Label (PDF - 761 KB)

Summary (PDF - 1.02 MB)

 

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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