Cleared Traditional

ACR LAB Urine Analysis Test System

K182384 · Healthy.Io, Ltd. · Chemistry
Jul 2019
Decision
329d
Days
Class 2
Risk

About This 510(k) Submission

K182384 is an FDA 510(k) clearance for the ACR LAB Urine Analysis Test System, a Enzymatic Method, Creatinine (Class II — Special Controls, product code JFY), submitted by Healthy.Io, Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on July 26, 2019, 329 days after receiving the submission on August 31, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K182384 FDA.gov
FDA Decision Cleared SESE
Date Received August 31, 2018
Decision Date July 26, 2019
Days to Decision 329 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JFY — Enzymatic Method, Creatinine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1225

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