ACR LAB Urine Analysis Test System— 510(k) K182384

Substantially Equivalent

Healthy.Io, Ltd.

FDA 510(k) clearance K182384 for ACR LAB Urine Analysis Test System, Substantially Equivalent on 2019-07-26. Applicant: Healthy.Io, Ltd..

Clearance details

Applicant: Healthy.Io, Ltd.
Product code: Code JFY
Advisory panel: Clinical Chemistry
Date received: 2018-08-31
Decision date: 2019-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tel Aviv, IL

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.