Minuteful - Kidney Test

Indicator Method, Protein Or Albumin (urinary, Non-quant.)

Healthy.io Ltd.

The following data is part of a premarket notification filed by Healthy.io Ltd. with the FDA for Minuteful - Kidney Test.

Pre-market Notification Details

Device IDK210069
510k NumberK210069
Device Name:Minuteful - Kidney Test
ClassificationIndicator Method, Protein Or Albumin (urinary, Non-quant.)
Applicant Healthy.io Ltd. 2 Ibn Gabirol St. Tel Aviv,  IL 6407702
ContactRon Zohar
CorrespondentRon Zohar
Healthy.io Ltd. 8 Yitzhak Sadeh St. Tel Aviv,  IL 6777508
Product CodeJIR  
Subsequent Product CodeJFY
Subsequent Product CodeKQO
CFR Regulation Number862.1645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-11
Decision Date2022-07-06

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