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Data / Medical devices / United States / Assure Tech LLC

Assure Tech LLC: FDA-registered device maker in Wilmington, DE, United States, 16 510(k) clearances

Assure Tech LLC is registered with the FDA (registration 3030648160) in Wilmington, DE, United States. It lists 49 device types. The FDA files 16 510(k) clearances under its listings, the newest dated June 5, 2026. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Assure Tech LLC
FDA registration number
3030648160
Address
1521 Concord Pike Suite 201, Wilmington, DE, United States, 19803
Owner or operator
Assure Tech LLC (10090182)
Roles
Repackager or relabeler, Specification developer
First device listed
February 26, 2024
Registered through
2026
Brand names listed
AssureTech Multi-drug Urine Test Cup, AssureTech Multi-drug Urine Test Panel, AssureTech Panel Dip Tests, AssureTech Quick Cup Tests, Breath Alcohol Test, FaStep Early Pregnancy Rapid Test Cassette, FaStep Early Pregnancy Rapid Test Midstream, FaStep Early Pregnancy Rapid Test Strip and more

Devices it lists

DeviceProduct codeClassRoleSource
Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)JMA1Repackager or relabeleraccessdata.fda.gov
Acid, Uric, Uricase (Colorimetric)KNK1Repackager or relabeleraccessdata.fda.gov
Device, Fertility Diagnostic, ProceptiveLHDUSpecification developeraccessdata.fda.gov
Devices, Breath Trapping, AlcoholDJZ1Repackager or relabeleraccessdata.fda.gov
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)JMT1Repackager or relabeleraccessdata.fda.gov
Dye-Indicator, Ph (Urinary, Non-Quantitative)CEN1Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, AmphetamineDKZ2Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, BarbiturateDIS2Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, BenzodiazepineJXM2Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, CannabinoidsLDJ2Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine MetabolitesDIO2Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, MethadoneDJR2Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, OpiatesDJG2Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, PhencyclidineLCMURepackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, PropoxypheneJXN2Repackager or relabeleraccessdata.fda.gov
Gas Chromatography, MethamphetamineLAF2Repackager or relabeleraccessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The CounterLCX2Repackager or relabeler, Specification developeraccessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)JIN1Repackager or relabeleraccessdata.fda.gov
Over-The-Counter Covid-19 Antigen TestQYT2Repackager or relabeler, Specification developeraccessdata.fda.gov
Radioimmunoassay, Tricyclic Antidepressant DrugsLFG2Repackager or relabeleraccessdata.fda.gov
Sperm, Antigen, Antiserum, ControlDFQ1Repackager or relabeleraccessdata.fda.gov
Test System, Nicotine, Cotinine, MetabolitesMRS1Repackager or relabeleraccessdata.fda.gov
Test, Amphetamine, Employment And Insurance Testing, ExemptPUX2Repackager or relabeleraccessdata.fda.gov
Test, Amphetamine, Over The CounterNFT2Repackager or relabeler, Specification developeraccessdata.fda.gov
Test, Barbiturate, Employment And Insurance Testing, ExemptPUY2Repackager or relabeleraccessdata.fda.gov
Test, Barbiturate, Over The CounterPTH2Repackager or relabeler, Specification developeraccessdata.fda.gov
Test, Benzodiazepine, Employment And Insurance Testing, ExemptPUZ2Repackager or relabeleraccessdata.fda.gov
Test, Benzodiazepine, Over The CounterNFV2Repackager or relabeler, Specification developeraccessdata.fda.gov
Test, Cannabinoid, Over The CounterNFW2Repackager or relabeler, Specification developeraccessdata.fda.gov
Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, ExemptPVA2Repackager or relabeleraccessdata.fda.gov
Test, Cocaine And Cocaine Metabolites, Over The CounterNFY2Repackager or relabeler, Specification developeraccessdata.fda.gov
Test, Follicle Stimulating Hormone (Fsh), Over The CounterNGA1Repackager or relabeleraccessdata.fda.gov
Test, Luteinizing Hormone (Lh), Over The CounterNGE1Repackager or relabeleraccessdata.fda.gov
Test, Methadone, Employment And Insurance Testing, ExemptPVE2Repackager or relabeleraccessdata.fda.gov
Test, Methadone, Over The CounterPTG2Repackager or relabeler, Specification developeraccessdata.fda.gov
Test, Methamphetamine, Employment And Insurance Testing, ExemptPVD2Repackager or relabeleraccessdata.fda.gov
Test, Methamphetamine, Over The CounterNGG2Repackager or relabeler, Specification developeraccessdata.fda.gov
Test, Methaqualone, Employment And Insurance Testing, ExemptPVF2Repackager or relabeleraccessdata.fda.gov
Test, Morphine, Employment And Insurance Testing, ExemptPVG2Repackager or relabeleraccessdata.fda.gov
Test, Opiates, Employment And Insurance Testing, ExemptPVH2Repackager or relabeleraccessdata.fda.gov
Test, Opiates, Over The CounterNGL2Repackager or relabeler, Specification developeraccessdata.fda.gov
Test, Phencyclidine (Pcp), Over The CounterNGMURepackager or relabeler, Specification developeraccessdata.fda.gov
Test, Propoxyphene, Employment And Insurance Testing, ExemptPVI2Repackager or relabeleraccessdata.fda.gov
Test, Propoxyphene, Over The CounterQBF2Repackager or relabeler, Specification developeraccessdata.fda.gov
Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, ExemptPVK2Repackager or relabeleraccessdata.fda.gov
Test, Tricyclic Antidepressants, Over The CounterQAW2Repackager or relabeler, Specification developeraccessdata.fda.gov
Test, Urine LeukocyteLJX1Repackager or relabeleraccessdata.fda.gov
Thin Layer Chromatography, MethamphetamineDJC2Repackager or relabeleraccessdata.fda.gov
Visual, Pregnancy Hcg, Prescription UseJHI2Repackager or relabeler, Specification developeraccessdata.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

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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.