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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 K173327
Device Name DIP/U.S. Urine Analysis Test System
Applicant
Healthy.io Ltd
27 Rothschild Boulevard
tel aviv,  IL 6688206
Applicant Contact ron zohar
Correspondent
Hogan Lovells US LLP
555 Thirteenth Street NW
washington,  DC  20004
Correspondent Contact john j. smith
Regulation Number862.1340
Classification Product Code
JIL  
Subsequent Product Codes
CEN   JIO   JIR   JMT   JRE  
Date Received10/20/2017
Decision Date 07/18/2018
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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