Cleared Traditional

inui In-Home Urine Analysis Test System

K180356 · Scanadu, Inc. · Chemistry

May 2018

Decision

106d

Days

Class 2

Risk

About This 510(k) Submission

K180356 is an FDA 510(k) clearance for the inui In-Home Urine Analysis Test System, a Method, Enzymatic, Glucose (urinary, Non-quantitative) (Class II — Special Controls, product code JIL), submitted by Scanadu, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on May 25, 2018, 106 days after receiving the submission on February 8, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1340.

Submission Details

510(k) Number	K180356 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 08, 2018
Decision Date	May 25, 2018
Days to Decision	106 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF