Cleared Traditional

Nova Max Uric Acid Monitoring System

K160990 · Nova Biomedical Corporation · Chemistry
Apr 2017
Decision
368d
Days
Class 1
Risk

About This 510(k) Submission

K160990 is an FDA 510(k) clearance for the Nova Max Uric Acid Monitoring System, a Uric Acid Test System For At Home Prescription Use (Class I — General Controls, product code PTC), submitted by Nova Biomedical Corporation (Walham, US). The FDA issued a Cleared decision on April 11, 2017, 368 days after receiving the submission on April 8, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1775.

Submission Details

510(k) Number K160990 FDA.gov
FDA Decision Cleared SESE
Date Received April 08, 2016
Decision Date April 11, 2017
Days to Decision 368 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code PTC — Uric Acid Test System For At Home Prescription Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1775
Definition For The Quantitative Measurement Of Uric Acid In Home Use Settings By Patients Diagnosed With Gout. This Device Is For Prescription Use Only.