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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
510(k) Number K252607
Device Name AllTest Urinary Tract Infection Test
Applicant
Hangzhou AllTest Biotech Co., Ltd.
#550 Yinhai St.
Hangzhou,  CN 310018
Applicant Contact Rosa Wu
Correspondent
LSI International, Inc.
504 E Diamond Ave.
Suite H
Gaithersburg,  MD  20877
Correspondent Contact Jenny Xia
Regulation Number862.1510
Classification Product Code
JMT  
Subsequent Product Code
LJX  
Date Received08/18/2025
Decision Date 10/30/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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