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FDA 510(k)

AssureTech Panel Dip Tests, AssureTech Quick Cup Tests

K-Number: K181768 · 2018-08-20

ApplicantAssure Tech. (Hangzhou) Co, Ltd.
Decision Date2018-08-20
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 2018-08-20 under approval number K181768. 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 2018-08-20. It is manufactured by Assure Tech. (Hangzhou) Co, Ltd.. The 510(k) number is K181768.

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 2018-08-20, under approval number K181768.

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.

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) K170049AssureTech Panel Dip Test, AssureTech Quick Cup Test 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)

K170049AssureTech Panel Dip Test, AssureTech Quick Cup TestAssure Tech. (Hangzhou) Co, Ltd. K182701Wondfo T-Cup Multi-Drug Urine Test CupGuangzhou Wondfo Biotech Co., Ltd. K182530BIOEASY Multi-Drug Test CupShenzhen Bioeasy Biotechnology Co., Ltd. K181968SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-CardSafecare Biotech (Hangzhou) Co., Ltd. K180349AssureTech Panel Dip Tests, AssureTech Quick Cup TestsAssure Tech. (Hangzhou) Co, Ltd. K171695First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test MarijuanaW.H.P.M., Inc.

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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