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.. Device class: 2.
Clearance details
- Applicant
- Fujimori Kogyo, Co., Ltd.
- Product code
- Code JOZ
- Device class
- Class 2
- Regulation
- 21 CFR 864.5700
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shinjuku, Tokyo, JP
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Data sourced from openFDA. This site is unofficial and independent of the FDA.