Devices · Healthy.io Ltd

ACR LAB Urine Analysis Test System

Healthy.io Ltd is listed for ACR LAB Urine Analysis Test System (K182384). The FDA list gives July 26, 2019 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 JFY. 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=K182384

Official FDA database record

Date of final decision

July 26, 2019

Company on the FDA list

Healthy.io Ltd

Lead panel

Clinical Chemistry

Primary product code

JFY

openFDA device name for the code

Enzymatic Method, Creatinine

Device class

2

Regulation number

862.1225

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary