Assure Tech LLC
Wilmington, DE, US
ASSURE TECH LLC appears in FDA device records in Wilmington, DE. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Assure Tech LLC between 2015 and 2026. The busiest year on record is 2025, with 4. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 2 |
| 2016 | 1 |
| 2024 | 1 |
| 2025 | 4 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261984 | AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup | NFT | Substantially Equivalent | |
| K260754 | Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test | QYT | Substantially Equivalent | |
| K252259 | AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup | NFT | Substantially Equivalent | |
| K250117 | FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette | LCX | Substantially Equivalent | |
| K243996 | AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup | NFT | Substantially Equivalent | |
| K243573 | FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream | LCX | Substantially Equivalent | |
| K240351 | FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine) | NGL | Substantially Equivalent | |
| K152768 | Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip | JHI | Substantially Equivalent | |
| K152025 | AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) | DJR | Substantially Equivalent | |
| K151211 | AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup | DIS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3030648160 | 3030648160 | ASSURE TECH LLC | 1521 Concord Pike Suite 201, Wilmington, DE 19803 US | 2026 | and 39 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JMAAcid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
- KNKAcid, Uric, Uricase (Colorimetric)
- LHDDevice, Fertility Diagnostic, Proceptive
- DJZDevices, Breath Trapping, Alcohol
- JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- CENDye-Indicator, Ph (Urinary, Non-Quantitative)
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJREnzyme Immunoassay, Methadone
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- JXNEnzyme Immunoassay, Propoxyphene
- LAFGas Chromatography, Methamphetamine
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- JINNitroprusside, Ketones (Urinary, Non-Quant.)
- QYTOver-The-Counter Covid-19 Antigen Test
- LFGRadioimmunoassay, Tricyclic Antidepressant Drugs
- DFQSperm, Antigen, Antiserum, Control
- MRSTest System, Nicotine, Cotinine, Metabolites
- PUXTest, Amphetamine, Employment And Insurance Testing, Exempt
- NFTTest, Amphetamine, Over The Counter
- PUYTest, Barbiturate, Employment And Insurance Testing, Exempt
- PTHTest, Barbiturate, Over The Counter
- PUZTest, Benzodiazepine, Employment And Insurance Testing, Exempt
- NFVTest, Benzodiazepine, Over The Counter
- NFWTest, Cannabinoid, Over The Counter
- PVATest, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt
- NFYTest, Cocaine And Cocaine Metabolites, Over The Counter
- NGATest, Follicle Stimulating Hormone (Fsh), Over The Counter
- NGETest, Luteinizing Hormone (Lh), Over The Counter
- PVETest, Methadone, Employment And Insurance Testing, Exempt
- PTGTest, Methadone, Over The Counter
- PVDTest, Methamphetamine, Employment And Insurance Testing, Exempt
- NGGTest, Methamphetamine, Over The Counter
- PVFTest, Methaqualone, Employment And Insurance Testing, Exempt
- PVGTest, Morphine, Employment And Insurance Testing, Exempt
- PVHTest, Opiates, Employment And Insurance Testing, Exempt
- NGLTest, Opiates, Over The Counter
- NGMTest, Phencyclidine (Pcp), Over The Counter
- PVITest, Propoxyphene, Employment And Insurance Testing, Exempt
- QBFTest, Propoxyphene, Over The Counter
- PVKTest, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt
- QAWTest, Tricyclic Antidepressants, Over The Counter
- LJXTest, Urine Leukocyte
- DJCThin Layer Chromatography, Methamphetamine
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain