510(k) K992531

ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM by Accumetrics, Inc. — Product Code JOZ

K992531 is an FDA 510(k) premarket notification submitted by Accumetrics, Inc. for the device "ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM". The FDA issued a decision of Substantially Equivalent on December 20, 1999. 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.