510(k) K021927

PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM by Biomet, Inc. — Product Code LXG

K021927 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM". The FDA issued a decision of Substantially Equivalent on July 12, 2002. The device falls under product code LXG (Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use), a Class I device regulated under 21 CFR 862.2050. Biomet, Inc. has at least 10 other 510(k) clearances on record.