FDA 510(k)

Minuteful - kidney test

K-Number: K210069 · 2022-07-06

Decision Date2022-07-06

Product CodeJIR

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Minuteful - kidney test is the device name listed in this FDA 510(k) record. The listed applicant is Healthy.Io, Ltd.. It received FDA 510(k) clearance on 2022-07-06 under 510(k) number K210069. 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 2022-07-06. The listed applicant is Healthy.Io, Ltd.. The 510(k) number is K210069.

When did Minuteful - kidney test receive FDA 510(k) clearance?

Minuteful - kidney test received FDA 510(k) clearance on 2022-07-06, under 510(k) number K210069.

Who is the listed applicant for Minuteful - kidney test?

The FDA 510(k) record lists Healthy.Io, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Healthy.Io, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222921Minuteful-kidney test K182384ACR LAB Urine Analysis Test System K173327DIP/U.S. Urine Analysis Test System

Related Devices (Code: JIR)

K222921Minuteful-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.