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FDA 510(k)

Minuteful-kidney test

K-Number: K222921 · 2023-09-08

ApplicantHealthy.Io, Ltd.
Decision Date2023-09-08
Product CodeJIR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Minuteful-kidney test is a medical device manufactured by Healthy.Io, Ltd.. It received FDA 510(k) clearance on 2023-09-08 under approval number K222921. The device is classified under product code JIR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Minuteful-kidney test?

Minuteful-kidney test is a medical device that received FDA 510(k) clearance on 2023-09-08. It is manufactured by Healthy.Io, Ltd.. The 510(k) number is K222921.

When was Minuteful-kidney test approved by the FDA?

Minuteful-kidney test received FDA 510(k) clearance on 2023-09-08, under approval number K222921.

What company makes Minuteful-kidney test?

Minuteful-kidney test is manufactured by Healthy.Io, Ltd..

What is the FDA product code for Minuteful-kidney test?

The FDA product code for Minuteful-kidney test is JIR.

Other Devices by Healthy.Io, Ltd.

K173327DIP/U.S. Urine Analysis Test System K182384ACR LAB Urine Analysis Test System K210069Minuteful - kidney test

Related Devices (Code: JIR)

K210069Minuteful - kidney testHealthy.Io, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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