Company ยท US
Assure Tech., LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2015 to 2026. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 17, 2026 | K261984 | AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup Assure Tech., LLC | NFT |
| Jun 5, 2026 | K260754 | Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test Assure Tech., LLC | QYT |
| Aug 15, 2025 | K252259 | AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup Assure Tech., LLC | NFT |
| Feb 13, 2025 | K250117 | FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette Assure Tech., LLC | LCX |
| Feb 7, 2025 | K243996 | AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Ur Assure Tech., LLC | NFT |
| Jan 15, 2025 | K243573 | FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test M Assure Tech., LLC | LCX |
| Mar 6, 2024 | K240351 | FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine) Assure Tech., LLC | NGL |
| Feb 24, 2016 | K152768 | Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip Assure Tech. Co., Ltd., CN | JHI |
| Oct 5, 2015 | K152025 | AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Pan Assure Tech. Co., Ltd., CN | DJR |
| Jun 4, 2015 | K151211 | AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secob Assure Tech. Co., Ltd., CN | DIS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||