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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 K222921
Device Name Minuteful-kidney test
Applicant
Healthy.io Ltd.
8 Yitzhak Sadeh Street
Tel Aviv,  IL 6777508
Applicant Contact Ron Zohar
Correspondent
Healthy.io Ltd.
8 Yitzhak Sadeh Street
Tel Aviv,  IL 6777508
Correspondent Contact Ron Zohar
Regulation Number862.1645
Classification Product Code
JIR  
Subsequent Product Codes
JFY   KQO  
Date Received09/26/2022
Decision Date 09/08/2023
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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