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FDA 510(k)

AssureTech Panel Dip Tests, AssureTech Quick Cup Tests

K-Number: K180349 · 2018-04-05

ApplicantAssure Tech. (Hangzhou) Co, Ltd.
Decision Date2018-04-05
Product CodeNFT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AssureTech Panel Dip Tests, AssureTech Quick Cup Tests is a medical device manufactured by Assure Tech. (Hangzhou) Co, Ltd.. It received FDA 510(k) clearance on 2018-04-05 under approval number K180349. The device is classified under product code NFT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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 2018-04-05. It is manufactured by Assure Tech. (Hangzhou) Co, Ltd.. The 510(k) number is K180349.

When was AssureTech Panel Dip Tests, AssureTech Quick Cup Tests approved by the FDA?

AssureTech Panel Dip Tests, AssureTech Quick Cup Tests received FDA 510(k) clearance on 2018-04-05, under approval number K180349.

What company makes AssureTech Panel Dip Tests, AssureTech Quick Cup Tests?

AssureTech Panel Dip Tests, AssureTech Quick Cup Tests is manufactured by Assure Tech. (Hangzhou) Co, Ltd..

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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