Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 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 2018-04-05 under 510(k) 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. The listed applicant is Assure Tech. (Hangzhou) Co, Ltd.. The 510(k) number is K180349.

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 2018-04-05, under 510(k) number K180349.

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.

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.

K233174FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test MidstreamK201630AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup TestsK181768AssureTech Panel Dip Tests, AssureTech Quick Cup TestsK170049AssureTech Panel Dip Test, AssureTech Quick Cup TestK161044AssureTech 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)

View all 7 devices →

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

View on FDA Database →

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

↑