K-numberK191364
Device nameT-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
ApplicantFujimori Kogyo, Co., Ltd.
Product codeJOZ
Device classClass II
Decision dateFeb 14, 2020
DecisionSubstantially Equivalent
Regulation864.5700
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