Cleared Traditional

DIP/U.S. Urine Analysis Test System

K173327 · Healthy.Io, Ltd. · Chemistry
Jul 2018
Decision
271d
Days
Class 2
Risk

About This 510(k) Submission

K173327 is an FDA 510(k) clearance for the DIP/U.S. Urine Analysis Test System, a Method, Enzymatic, Glucose (urinary, Non-quantitative) (Class II — Special Controls, product code JIL), submitted by Healthy.Io, Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on July 18, 2018, 271 days after receiving the submission on October 20, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1340.

Submission Details

510(k) Number K173327 FDA.gov
FDA Decision Cleared SESE
Date Received October 20, 2017
Decision Date July 18, 2018
Days to Decision 271 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIL — Method, Enzymatic, Glucose (urinary, Non-quantitative)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1340

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