QSCHECK UISACR— 510(k) K252619
Substantially EquivalentQstag, Inc.
FDA 510(k) clearance K252619 for QSCHECK UISACR, Substantially Equivalent on 2026-02-20. Applicant: Qstag, Inc.. Device class: 2.
Summary
Qstag's QSCHECK UISACR is filed under product code JFY, enzymatic method, creatinine. The record doesn't describe the device beyond its name and that code name.
Class II, 21 CFR 862.1225. Clinical Chemistry is both the classification panel and the review panel. It came in as a Traditional 510(k).
Qstag filed from Incheon, South Korea. FDA found it substantially equivalent 185 calendar days after receipt (August 19, 2025 to February 20, 2026).
Clearance details
- Applicant
- Qstag, Inc.
- Product code
- Product code JFY
- Device class
- Class 2
- Regulation
- 21 CFR 862.1225
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Incheon, KR
Recent devices under product code JFY
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