Cleared Traditional

Nova Primary Glucose Analyzer System

K203549 · Nova Biomedical Corporation · Chemistry
Oct 2022
Decision
683d
Days
Class 2
Risk

About This 510(k) Submission

K203549 is an FDA 510(k) clearance for the Nova Primary Glucose Analyzer System, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Nova Biomedical Corporation (Waltham, US). The FDA issued a Cleared decision on October 18, 2022, 683 days after receiving the submission on December 4, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K203549 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 2020
Decision Date October 18, 2022
Days to Decision 683 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGA — Glucose Oxidase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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