QSCHECK UISACR— 510(k) K252619

Substantially Equivalent

Qstag, Inc.

FDA 510(k) clearance K252619 for QSCHECK UISACR, Substantially Equivalent on 2026-02-20. Applicant: Qstag, Inc.. Device class: 2.

Clearance details

Applicant: Qstag, Inc.
Product code: Code JFY
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 2025-08-19
Decision date: 2026-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Incheon, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.