510(k) K191364

T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01 by Fujimori Kogyo, Co., Ltd. — Product Code JOZ

K191364 is an FDA 510(k) premarket notification submitted by Fujimori Kogyo, Co., Ltd. for the device "T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01". The FDA issued a decision of Substantially Equivalent on February 14, 2020. The device falls under product code JOZ (System, Automated Platelet Aggregation), a Class II device regulated under 21 CFR 864.5700.