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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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2020
Date Received
May 22, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Automated Platelet Aggregation
Device Class
Class II
Regulation Number
864.5700
Review Panel
HE
Submission Type

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