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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Stem Cell Concentration System

Product: Stem Cell Concentration System
Applicant:
CellPro, Inc. Bothell, WA
PMA number:
BP940001
Indication for use:
For the processing of autologous bone marrow to obtain a CD34+cell enriched population which is intended for hematopoietic support after myeloablative chemotherapy.
Approval Date:
12/6/96



Letter - (PDF), (Text)

Summary - (PDF)

 

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