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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Isolex 300 & 300i Magnetic Cell Selection System

Product: Isolex 300 & 300i Magnetic Cell Selection System
Applicant: Nexell Therapeutics, Inc., Irvine, CA
PMA number: BP970001 & BP970001 Supplement 01
Indication for Use: Processing autologuous peripheral blood progenitor cell (PBPC) products to obtain a CD 34+ cell enriched population intended for hematopoietic reconstitution after myeloablative therapy in patients with CD 34-negative tumors.
Approval Date: 7/2/99

Letter (PDF), (Text)

Label (PDF)

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
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