K252619
- 510(k) number
- K252619
- Device name
- QSCHECK UISACR
- Applicant
- Qstag, Inc. KR
- Product code
- JFY — Enzymatic Method, Creatinine
- Decision date
- 2026-02-20
- Date received
- 2025-08-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
510(k) Summary (official FDA PDF): K252619.pdf
Official FDA record: K252619
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.