Cleared Traditional

Stat Profile Prime Plus Analyzer System

K200349 · Nova Biomedical Corporation · Chemistry
Mar 2020
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K200349 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 March 13, 2020, 30 days after receiving the submission on February 12, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K200349 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 2020
Decision Date March 13, 2020
Days to Decision 30 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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