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FDA 510(k)

AssureTech Panel Dip Test, AssureTech Quick Cup Test

K-Number: K170049 · 2017-05-02

ApplicantAssure Tech. (Hangzhou) Co, Ltd.
Decision Date2017-05-02
Product CodeNFT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AssureTech Panel Dip Test, AssureTech Quick Cup Test 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 2017-05-02 under 510(k) number K170049. 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 Test, AssureTech Quick Cup Test?

AssureTech Panel Dip Test, AssureTech Quick Cup Test is a medical device that received FDA 510(k) clearance on 2017-05-02. The listed applicant is Assure Tech. (Hangzhou) Co, Ltd.. The 510(k) number is K170049.

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

AssureTech Panel Dip Test, AssureTech Quick Cup Test received FDA 510(k) clearance on 2017-05-02, under 510(k) number K170049.

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

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 Test, AssureTech Quick Cup Test?

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

Other records listing Assure Tech. (Hangzhou) Co, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: NFT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261984AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test CupAssure Tech., LLCK261280BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test PanelVivachek Biotech (Hangzhou) Co., Ltd.K260065SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel DxGuangzhou Wondfo Biotech Co., Ltd.K260355Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine CupWEBEST Biotech,, LLCK252550SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup DxGuangzhou Wondfo Biotech Co., Ltd.K252867VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test CupAdvin Biotech, Inc.

Official Source

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

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