The following data is part of a premarket notification filed by Fujimori Kogyo Co., Ltd. with the FDA for 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.
| Device ID | K191364 |
| 510k 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 |
| Classification | System, Automated Platelet Aggregation |
| Applicant | Fujimori Kogyo Co., Ltd. Shinjuku First West 1-23-7 Nishi-Shinjuku Shinjuku, Tokyo, JP 160-0023 |
| Contact | Jeffrey Dahlen |
| Correspondent | Jeffrey Dahlen Fujimori Kogyo Co., Ltd. 11435 Merritage Court San Diego, CA 92131 |
| Product Code | JOZ |
| CFR Regulation Number | 864.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-22 |
| Decision Date | 2020-02-14 |