Cleared Traditional

Stat Profile Prime Plus Analyzer System

K180428 · Nova Biomedical Corporation · Chemistry
Aug 2018
Decision
180d
Days
Class 2
Risk

About This 510(k) Submission

K180428 is an FDA 510(k) clearance for the Stat Profile Prime Plus Analyzer System, a Electrode, Ion Specific, Sodium (Class II — Special Controls, product code JGS), submitted by Nova Biomedical Corporation (Walham, US). The FDA issued a Cleared decision on August 15, 2018, 180 days after receiving the submission on February 16, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.

Submission Details

510(k) Number K180428 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 2018
Decision Date August 15, 2018
Days to Decision 180 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JGS — Electrode, Ion Specific, Sodium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1665

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