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FDA 510(k)

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

Número K: K191364 · 2020-02-14

RequerenteFujimori Kogyo, Co., Ltd.
Data da decisão2020-02-14
Código do produtoJOZ
Comité consultivoHE
DecisãoSubstantially Equivalent

Resumo do dispositivo

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 is the device name listed in this FDA 510(k) record. The listed applicant is Fujimori Kogyo, Co., Ltd.. It received FDA 510(k) clearance on 2020-02-14 under 510(k) number K191364. The device is classified under product code JOZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is 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?

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 is a medical device that received FDA 510(k) clearance on 2020-02-14. The listed applicant is Fujimori Kogyo, Co., Ltd.. The 510(k) number is K191364.

When did 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 receive FDA 510(k) clearance?

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 received FDA 510(k) clearance on 2020-02-14, under 510(k) number K191364.

Who is the listed applicant 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?

The FDA 510(k) record lists Fujimori Kogyo, Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code 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?

The FDA product code 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 is JOZ.

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