510(k) K191364 ยท JOZ System, Automated Platelet Aggregation
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, Tokyo, JP |
| Decision | Substantially Equivalent, Feb 14, 2020 |
| Received | May 22, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191364
No recall in the FDA data names this 510(k).
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