Cleared Traditional

Stat Profile Prime Plus Analyzer System

K180340 · Nova Biomedical Corporation · Chemistry
Sep 2018
Decision
231d
Days
Class 2
Risk

About This 510(k) Submission

K180340 is an FDA 510(k) clearance for the Stat Profile Prime Plus Analyzer System, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Nova Biomedical Corporation (Walham, US). The FDA issued a Cleared decision on September 26, 2018, 231 days after receiving the submission on February 7, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K180340 FDA.gov
FDA Decision Cleared SESE
Date Received February 07, 2018
Decision Date September 26, 2018
Days to Decision 231 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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