Medical Device Manufacturer · US , Menlo Park , CA

Qurasense - FDA 510(k) Cleared Devices

1 submissions · 1 cleared · Since 2023

Total

Cleared

Denied

Qurasense has 1 FDA 510(k) cleared medical devices. Based in Menlo Park, US.

Last cleared in 2023. Active since 2023. Primary specialty: Chemistry.

Browse the FDA 510(k) cleared devices submitted by Qurasense Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Hyman, Phelps & McNamara, P.C. as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov.

FDA 510(k) Regulatory Record - Qurasense

1 devices

1-1 of 1

Cleared CT Dec 06, 2023

Q-Pad Test System

K231465 · LCP

Chemistry · 201d

Regulatory Intelligence

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

Qurasense - FDA 510(k) Cleared Devices

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