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FDA grants 510(k) clearance to Fenwal to market Amicus blood cell separator for platelet-related use
Thursday, March 11 2010 | Comments
What's This?
The Food and Drug Administration granted 510(k) marketing clearance to Fenwal Inc.'s Amicus blood cell separator for collecting human platelets stored in the company's InterSol platelet additive solution.In December, the regulatory agency approved the InterSol platelet additive, which gave blood banks the option of storing platelets in a mixture of 65 percent InterSol solution and 35 percent plasma rather than in 100 percent donated human plasma, the traditional vehicle.
With the new FDA clearance, InterSol solution can now be used for the first time with an approved platelet-collection and storage system, Fenwal noted.
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