FDA 510(k)

AssureTech Panel Dip Tests, AssureTech Quick Cup Tests

Número K: K181768 · 2018-08-20

RequerenteAssure Tech. (Hangzhou) Co, Ltd.

Data da decisão2018-08-20

Código do produtoNFT

Comité consultivoTX

DecisãoSubstantially Equivalent

Resumo do dispositivo

AssureTech Panel Dip Tests, AssureTech Quick Cup Tests is the device name listed in this FDA 510(k) record. The listed applicant is Assure Tech. (Hangzhou) Co, Ltd.. It received FDA 510(k) clearance on 2018-08-20 under 510(k) number K181768. The device is classified under product code NFT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AssureTech Panel Dip Tests, AssureTech Quick Cup Tests?

AssureTech Panel Dip Tests, AssureTech Quick Cup Tests is a medical device that received FDA 510(k) clearance on 2018-08-20. The listed applicant is Assure Tech. (Hangzhou) Co, Ltd.. The 510(k) number is K181768.

When did AssureTech Panel Dip Tests, AssureTech Quick Cup Tests receive FDA 510(k) clearance?

AssureTech Panel Dip Tests, AssureTech Quick Cup Tests received FDA 510(k) clearance on 2018-08-20, under 510(k) number K181768.

Who is the listed applicant for AssureTech Panel Dip Tests, AssureTech Quick Cup Tests?

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

What is the FDA product code for AssureTech Panel Dip Tests, AssureTech Quick Cup Tests?

The FDA product code for AssureTech Panel Dip Tests, AssureTech Quick Cup Tests is NFT.

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