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

Name: FDA 510(k) clearance K182384
Creator: U.S. Food and Drug Administration
Published: 2019-07-26

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.. Device class: 2.

Clearance details

Applicant: Healthy.Io, Ltd.
Product code: Code JFY
Device class: Class 2
Regulation: 21 CFR 862.1225
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 ↗

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