510(k) K012701

ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA) by Accumetrics, Inc. — Product Code JOZ

K012701 is an FDA 510(k) premarket notification submitted by Accumetrics, Inc. for the device "ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA)". The FDA issued a decision of Substantially Equivalent on June 12, 2002. The device falls under product code JOZ (System, Automated Platelet Aggregation), a Class II device regulated under 21 CFR 864.5700. Accumetrics, Inc. has at least 6 other 510(k) clearances on record.