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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name method, enzymatic, glucose (urinary, non-quantitative)
510(k) Number K180356
Device Name inui In-Home Urine Analysis Test System
Applicant
Scanadu, Inc.
1196 Borregas Ave., Ste 200
sunnyvale,  CA  94089
Applicant Contact daya ranamukhaarachchi
Correspondent
Scanadu, Inc.
1196 Borregas Ave., Ste 200
sunnyvale,  CA  94089
Correspondent Contact daya ranamukhaarachchi
Regulation Number862.1340
Classification Product Code
JIL  
Subsequent Product Codes
JIN   JIR   JMT   LJX  
Date Received02/08/2018
Decision Date 05/25/2018
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
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