Assure Tech., LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Assure Tech., LLC - FDA 510(k) Cleared Devices
Recent clearances: Fastep COVID-19 Antigen Pen Home Test, AssureTech Quick Cup Tests, FaStep Pregnancy Rapid Test Cassette
6
Total
6
Cleared
0
Denied
Assure Tech., LLC has 6 FDA 510(k) cleared medical devices. Based in Wilmington, US.
Latest FDA clearance: Jun 2026. Active since 2024. Primary specialty: Toxicology.
Browse the FDA 510(k) cleared devices submitted by Assure Tech., LLC Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by LSI International, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Assure Tech., LLC
6 devices
Cleared
Jun 05, 2026
Fastep COVID-19 Antigen Pen Home Test
Microbiology
88d
Cleared
Aug 15, 2025
AssureTech Quick Cup Tests
Toxicology
25d
Cleared
Feb 13, 2025
FaStep Pregnancy Rapid Test Cassette
Chemistry
28d
Cleared
Feb 07, 2025
AssureTech Panel Dip Tests
Toxicology
43d
Cleared
Jan 15, 2025
FaStep Early Pregnancy Rapid Test Strip
Chemistry
57d
Cleared
Mar 06, 2024
FaStep Fentanyl Rapid Test Device (Urine)
Toxicology
30d