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Data / Medical devices / China / Assure Tech. (Hangzhou) Co., Ltd.

Assure Tech. (Hangzhou) Co., Ltd.: FDA-registered device maker in Hangzhou Zhejiang, China, 18 510(k) clearances

Assure Tech. (Hangzhou) Co., Ltd. is registered with the FDA (registration 3038560224) in Hangzhou Zhejiang, China. It lists 48 device types. The FDA files 18 510(k) clearances under its listings, the newest dated June 5, 2026. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Assure Tech. (Hangzhou) Co., Ltd.
FDA registration number
3038560224
Address
No.128, Chunting Road, Fuyang District, Hangzhou, 311400 Zhejiang P.R. China, Hangzhou Zhejiang, China, 311400
Owner or operator
Assure Tech. (Hangzhou) Co., Ltd. (10040710)
Roles
Contract manufacturer, Manufacturer
First device listed
July 31, 2012
Registered through
2026
Brand names listed
ASSURETECH DOA DIPSTICK SCREEN PANEL TESTS, ASSURETECH DOA INTEGRATED CUP TESTS, Areta Cocaine Test Strip (ASCOC-114), Areta Cotinine Test Strip, ASCOT-114C, Areta Marijuana Test Strip, ASTH-114C, Areta Multi-Drug Screen Test, ADTP-1124, Areta Multi-Drug Screen Test, ADTP-254, Areta Multi-Drug Screen Test, ADTP-3104 and more

Devices it lists

DeviceProduct codeClassRoleSource
Devices, Breath Trapping, AlcoholDJZ1Manufactureraccessdata.fda.gov
Enzyme Immunoassay, AmphetamineDKZ2Contract manufacturer, Manufactureraccessdata.fda.gov
Enzyme Immunoassay, BarbiturateDIS2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, BenzodiazepineJXM2Contract manufacturer, Manufactureraccessdata.fda.gov
Enzyme Immunoassay, CannabinoidsLDJ2Contract manufacturer, Manufactureraccessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine MetabolitesDIO2Contract manufacturer, Manufactureraccessdata.fda.gov
Enzyme Immunoassay, MethadoneDJR2Contract manufacturer, Manufactureraccessdata.fda.gov
Enzyme Immunoassay, OpiatesDJG2Contract manufacturer, Manufactureraccessdata.fda.gov
Enzyme Immunoassay, PhencyclidineLCMUContract manufacturer, Manufactureraccessdata.fda.gov
Enzyme Immunoassay, PropoxypheneJXN2Manufactureraccessdata.fda.gov
Gas Chromatography, MethamphetamineLAF2Contract manufacturer, Manufactureraccessdata.fda.gov
Immunoassay, Pregnanediol Glucuronide, Over The CounterQKE1Manufactureraccessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The CounterLCX2Manufactureraccessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)JIN1Manufactureraccessdata.fda.gov
Over-The-Counter Covid-19 Antigen TestQYT2Manufactureraccessdata.fda.gov
Paper, Obstetric PhLNW1Manufactureraccessdata.fda.gov
Radioimmunoassay, Tricyclic Antidepressant DrugsLFG2Manufactureraccessdata.fda.gov
Reagent, Coronavirus SerologicalQKONManufactureraccessdata.fda.gov
Sperm, Antigen, Antiserum, ControlDFQ1Manufactureraccessdata.fda.gov
Test System, Nicotine, Cotinine, MetabolitesMRS1Manufactureraccessdata.fda.gov
Test, Amphetamine, Employment And Insurance Testing, ExemptPUX2Manufactureraccessdata.fda.gov
Test, Amphetamine, Over The CounterNFT2Manufactureraccessdata.fda.gov
Test, Barbiturate, Employment And Insurance Testing, ExemptPUY2Manufactureraccessdata.fda.gov
Test, Barbiturate, Over The CounterPTH2Manufactureraccessdata.fda.gov
Test, Benzodiazepine, Employment And Insurance Testing, ExemptPUZ2Manufactureraccessdata.fda.gov
Test, Benzodiazepine, Over The CounterNFV2Manufactureraccessdata.fda.gov
Test, Cannabinoid, Employment And Insurance Testing, ExemptPVJ2Manufactureraccessdata.fda.gov
Test, Cannabinoid, Over The CounterNFW2Manufactureraccessdata.fda.gov
Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, ExemptPVA2Manufactureraccessdata.fda.gov
Test, Cocaine And Cocaine Metabolites, Over The CounterNFY2Manufactureraccessdata.fda.gov
Test, Follicle Stimulating Hormone (Fsh), Over The CounterNGA1Manufactureraccessdata.fda.gov
Test, Luteinizing Hormone (Lh), Over The CounterNGE1Manufactureraccessdata.fda.gov
Test, Methadone, Employment And Insurance Testing, ExemptPVE2Manufactureraccessdata.fda.gov
Test, Methadone, Over The CounterPTG2Manufactureraccessdata.fda.gov
Test, Methamphetamine, Employment And Insurance Testing, ExemptPVD2Manufactureraccessdata.fda.gov
Test, Methamphetamine, Over The CounterNGG2Manufactureraccessdata.fda.gov
Test, Methaqualone, Employment And Insurance Testing, ExemptPVF2Manufactureraccessdata.fda.gov
Test, Morphine, Employment And Insurance Testing, ExemptPVG2Manufactureraccessdata.fda.gov
Test, Opiates, Employment And Insurance Testing, ExemptPVH2Manufactureraccessdata.fda.gov
Test, Opiates, Over The CounterNGL2Manufactureraccessdata.fda.gov
Test, Phencyclidine (Pcp), Over The CounterNGMUManufactureraccessdata.fda.gov
Test, Propoxyphene, Employment And Insurance Testing, ExemptPVI2Manufactureraccessdata.fda.gov
Test, Propoxyphene, Over The CounterQBF2Manufactureraccessdata.fda.gov
Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, ExemptPVK2Manufactureraccessdata.fda.gov
Test, Tricyclic Antidepressants, Over The CounterQAW2Manufactureraccessdata.fda.gov
Thin Layer Chromatography, MethamphetamineDJC2Contract manufacturer, Manufactureraccessdata.fda.gov
Thin Layer Chromatography, MorphineDNK2Contract manufactureraccessdata.fda.gov
Visual, Pregnancy Hcg, Prescription UseJHI2Contract manufacturer, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 5, 2026K260754Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen TestQYTSubstantially EquivalentAssure Tech., LLCaccessdata.fda.gov
August 15, 2025K252259AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test CupNFTSubstantially EquivalentAssure Tech., LLCaccessdata.fda.gov
February 13, 2025K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteLCXSubstantially EquivalentAssure Tech., LLCaccessdata.fda.gov
February 7, 2025K243996AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test CupNFTSubstantially EquivalentAssure Tech., LLCaccessdata.fda.gov
January 15, 2025K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test MidstreamLCXSubstantially EquivalentAssure Tech., LLCaccessdata.fda.gov
March 6, 2024K240351FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)NGLSubstantially EquivalentAssure Tech., LLCaccessdata.fda.gov
February 5, 2024K233174FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test MidstreamLCXSubstantially EquivalentAssure Tech. (Hangzhou) Co, Ltd.accessdata.fda.gov
August 12, 2021K201630AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup TestsDJGSubstantially EquivalentAssure Tech. (Hangzhou) Co, Ltd.accessdata.fda.gov
August 20, 2018K181768AssureTech Panel Dip Tests, AssureTech Quick Cup TestsNFTSubstantially EquivalentAssure Tech. (Hangzhou) Co, Ltd.accessdata.fda.gov
April 5, 2018K180349AssureTech Panel Dip Tests, AssureTech Quick Cup TestsNFTSubstantially EquivalentAssure Tech. (Hangzhou) Co, Ltd.accessdata.fda.gov
May 2, 2017K170049AssureTech Panel Dip Test, AssureTech Quick Cup TestNFTSubstantially EquivalentAssure Tech. (Hangzhou) Co, Ltd.accessdata.fda.gov
July 6, 2016K161044AssureTech 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)DJCSubstantially EquivalentAssure Tech. (Hangzhou) Co, Ltd.accessdata.fda.gov
March 31, 2016K153465AssureTech 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)DKZSubstantially EquivalentAssure Tech. (Hangzhou) Co, Ltd.accessdata.fda.gov
February 24, 2016K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test StripJHISubstantially EquivalentAssure Tech. Co., Ltd.accessdata.fda.gov
October 5, 2015K152025AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)DJRSubstantially EquivalentAssure Tech. Co., Ltd.accessdata.fda.gov
June 4, 2015K151211AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split CupDISSubstantially EquivalentAssure Tech. Co., Ltd.accessdata.fda.gov
March 14, 2013K122907FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTERLCXSubstantially EquivalentPolymed Therapeutics, Inc.accessdata.fda.gov
July 17, 2012K112101FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTSJHISubstantially EquivalentPolymed Therapeutics, Inc.accessdata.fda.gov

Compare with other makers

Updated June 5, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.