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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 K182384
Device Name ACR LAB Urine Analysis Test System
Applicant
Healthy.io Ltd
2 Ibn Gabirol
Tel Aviv,  IL 6407702
Applicant Contact Ron Zohar
Correspondent
Healthy.io Ltd
2 Ibn Gabirol
Tel Aviv,  IL 6407702
Correspondent Contact Ron Zohar
Regulation Number862.1225
Classification Product Code
JFY  
Subsequent Product Codes
JIR   KQO  
Date Received08/31/2018
Decision Date 07/26/2019
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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