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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Automated Platelet Aggregation
510(k) Number K191364
Device Name 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
Applicant
Fujimori Kogyo, Co., Ltd.
Shinjuku First W. 1-23-7 Nishi-Shinjuku
Shinjuku, Tokyo,  JP 160-0023
Applicant Contact Jeffrey Dahlen
Correspondent
Fujimori Kogyo, Co., Ltd.
11435 Merritage Court
San Diego,  CA  92131
Correspondent Contact Jeffrey Dahlen
Regulation Number864.5700
Classification Product Code
JOZ  
Date Received05/22/2019
Decision Date 02/14/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT03621020
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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