Cleared Traditional

Q-Pad Test System

K231465 · Qurasense · Chemistry

Dec 2023

Decision

201d

Days

Class 2

Risk

About This 510(k) Submission

K231465 is an FDA 510(k) clearance for the Q-Pad Test System, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Qurasense (Menlo Park, US). The FDA issued a Cleared decision on December 6, 2023, 201 days after receiving the submission on May 19, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number	K231465 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 19, 2023
Decision Date	December 06, 2023
Days to Decision	201 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF