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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Method, Creatinine
510(k) Number K252619
Device Name QSCHECK UISACR
Applicant
Qstag, Inc.
2104, Bldg. M, 32 Songdo Science-Ro, Yeonsu-Gu
Incheon,  KR 21984
Applicant Contact Junhyuck Jang
Correspondent
Qstag, Inc.
2104, Bldg. M, 32 Songdo Science-Ro, Yeonsu-Gu
Incheon,  KR 21984
Correspondent Contact Junhyuck Jang
Regulation Number862.1225
Classification Product Code
JFY  
Subsequent Product Codes
JIR   KQO  
Date Received08/19/2025
Decision Date 02/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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