Cleared Traditional

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

K191364 · Fujimori Kogyo, Co., Ltd. · Hematology

Feb 2020

Decision

268d

Days

Class 2

Risk

About This 510(k) Submission

K191364 is an FDA 510(k) clearance for the 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, a System, Automated Platelet Aggregation (Class II — Special Controls, product code JOZ), submitted by Fujimori Kogyo, Co., Ltd. (Shinjuku, Tokyo, JP). The FDA issued a Cleared decision on February 14, 2020, 268 days after receiving the submission on May 22, 2019. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5700.

Submission Details

510(k) Number	K191364 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 22, 2019
Decision Date	February 14, 2020
Days to Decision	268 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF