Devices · Healthy.io Ltd.

Minuteful-kidney test

Healthy.io Ltd. is listed for Minuteful-kidney test (K222921). The FDA list gives September 8, 2023 as the date of the final decision. The lead panel is Clinical Chemistry, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is JIR. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222921

Official FDA database record

Date of final decision

September 8, 2023

Company on the FDA list

Healthy.io Ltd.

Lead panel

Clinical Chemistry

Primary product code

JIR

openFDA device name for the code

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Device class

1

Regulation number

862.1645

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary