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— 510(k) K191364
Substantially EquivalentFujimori Kogyo, Co., Ltd.
FDA 510(k) clearance K191364 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, Substantially Equivalent on 2020-02-14. Applicant: Fujimori Kogyo, Co., Ltd..
Clearance details
- Applicant
- Fujimori Kogyo, Co., Ltd.
- Product code
- Code JOZ
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shinjuku, Tokyo, JP
Data sourced from openFDA. This site is unofficial and independent of the FDA.