Cleared Special

Nova StatSensor Creatinine Hospital Meter System

K171059 · Nova Biomedical Corporation · Chemistry
May 2017
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K171059 is an FDA 510(k) clearance for the Nova StatSensor Creatinine Hospital Meter System, a Electrode, Ion Based, Enzymatic, Creatinine (Class II — Special Controls, product code CGL), submitted by Nova Biomedical Corporation (Walham, US). The FDA issued a Cleared decision on May 26, 2017, 46 days after receiving the submission on April 10, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K171059 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 2017
Decision Date May 26, 2017
Days to Decision 46 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGL — Electrode, Ion Based, Enzymatic, Creatinine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1225

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