Medical Device Manufacturer · US , Menlo Park , CA

Qurasense - FDA 510(k) Cleared Devices

1 submissions · 1 cleared · Since 2023

Total

Cleared

Denied

FDA 510(k) Regulatory Record - Qurasense Chemistry ✕

1 devices

1-1 of 1

Linked clinical trials FDA-regulated device evidence

Regulatory consultant 510(k) submission support ecosystem

Hyman, Phelps & McNamara, P.C.

Regulatory activity signals

510(k) clearance pathway relevance detected

Medical device regulatory intelligence node

Consulting ecosystem involvement present

Clinical validation data available

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 16, 2026