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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 K251800
Device Name Healgen® URS Test Strips
Applicant
Healgen Scientific, LLC
3818 Fuqua St.,
Houston,  TX  77047
Applicant Contact Jianqui Fang
Correspondent
LSI International, Inc.
504e Diamond Ave.
Suite H
Gaithersburg,  MD  20877
Correspondent Contact Jenny Xia
Regulation Number862.1510
Classification Product Code
JMT  
Subsequent Product Code
LJX  
Date Received06/12/2025
Decision Date 12/23/2025
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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