Cleared Traditional

QSCHECK UISACR

K252619 · Qstag, Inc. · Chemistry

Feb 2026

Decision

185d

Days

Class 2

Risk

About This 510(k) Submission

K252619 is an FDA 510(k) clearance for the QSCHECK UISACR, a Enzymatic Method, Creatinine (Class II — Special Controls, product code JFY), submitted by Qstag, Inc. (Incheon, KR). The FDA issued a Cleared decision on February 20, 2026, 185 days after receiving the submission on August 19, 2025. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number	K252619 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 19, 2025
Decision Date	February 20, 2026
Days to Decision	185 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF