← Every applicant
Assure Tech., LLC FDA Approvals
0 new drug approvals and 7 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup510(k)Jul 17, 2026Clinical Toxicology |
| Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test510(k)Jun 5, 2026Microbiology |
| AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup510(k)Aug 15, 2025Clinical Toxicology |
| FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette510(k)Feb 13, 2025Clinical Chemistry |
| AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup510(k)Feb 7, 2025Clinical Toxicology |
| FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream510(k)Jan 15, 2025Clinical Chemistry |
| FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)510(k)Mar 6, 2024Clinical Toxicology |