510(k) K060489

DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS by Dade Behring, Inc. — Product Code JOZ

K060489 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS". The FDA issued a decision of Substantially Equivalent on July 21, 2006. The device falls under product code JOZ (System, Automated Platelet Aggregation), a Class II device regulated under 21 CFR 864.5700. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.