Cleared Traditional

Minuteful-kidney test

K222921 · Healthy.Io, Ltd. · Chemistry
Sep 2023
Decision
347d
Days
Class 1
Risk

About This 510(k) Submission

K222921 is an FDA 510(k) clearance for the Minuteful-kidney test, a Indicator Method, Protein Or Albumin (urinary, Non-quant.) (Class I — General Controls, product code JIR), submitted by Healthy.Io, Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on September 8, 2023, 347 days after receiving the submission on September 26, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1645.

Submission Details

510(k) Number K222921 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2022
Decision Date September 08, 2023
Days to Decision 347 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIR — Indicator Method, Protein Or Albumin (urinary, Non-quant.)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1645

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