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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name indicator method, protein or albumin (urinary, non-quant.)
510(k) Number K210069
Device Name Minuteful - kidney test
Applicant
Healthy.io Ltd.
2 Ibn Gabirol St.
Tel Aviv,  IL 6407702
Applicant Contact Ron Zohar
Correspondent
Healthy.io Ltd.
8 Yitzhak Sadeh St.
Tel Aviv,  IL 6777508
Correspondent Contact Ron Zohar
Regulation Number862.1645
Classification Product Code
JIR  
Subsequent Product Codes
JFY   KQO  
Date Received01/11/2021
Decision Date 07/06/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT04626271
Reviewed by Third Party No
Combination Product No
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