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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 a medical device manufactured by Assure Tech. (Hangzhou) Co, Ltd.. It received FDA 510(k) clearance on 2017-05-02 under approval 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. It is manufactured by Assure Tech. (Hangzhou) Co, Ltd.. The 510(k) number is K170049.

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

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

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

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

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 Devices by Assure Tech. (Hangzhou) Co, Ltd.

K161044AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) K153465AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup) K181768AssureTech Panel Dip Tests, AssureTech Quick Cup Tests K180349AssureTech Panel Dip Tests, AssureTech Quick Cup Tests K201630AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests K233174FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream

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Related Devices (Code: 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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